Health & Medical Data Research · Results
What the snapshot has produced.
Every figure on this page was computed from a dated snapshot of public federal data by the published extraction and analysis package, and nothing on this page exists that the snapshot did not produce.
Pending
No figure has been computed yet.
The adverse-event snapshot has not been taken. When it is, this page is regenerated from it: the headline figures, every table and every figure appear here only after the extraction and analysis package has produced them, and the snapshot date is stated beside them. The design and the coding schema are already public on the methods page.
Verified references
What was checked before any data were pulled.
The literature the analysis positions itself against, with every identifier resolved in PubMed on the date shown, and the registered trials with posted results that the trial comparison draws on.
| nct id | title | status | phase | conditions | interventions | sponsor | enrollment | start date | primary completion date | study type | robotic gyn relevance |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00683293 | Laparoscopic Hysterectomy: a Clinical Randomized Trial Comparing Conventional and Robot-assisted (Da Vinci) Techniques | COMPLETED | NA | Laparoscopic Technique no Switch to Open; Duration of Surgery; Intraoperative Complications; Postoperative Complications | Conventional Laparoscopic Hysterectomy; Robot-assisted (Da Vinci) laparoscopic hysterectomy | Kantonsspital Aarau | 100 | 2008-11 | 2011-09 | INTERVENTIONAL | core: robotic vs lap hysterectomy RCT; conversion and complications are registered outcomes |
| NCT00895284 | Laparoscopic Hysterectomy With and Without Robotic Assistance: a Randomized Prospective Trial | TERMINATED | PHASE4 | Hysterectomy | Robotic hysterectomy; Standard Hysterectomy | Mayo Clinic | 3 | 2007-03 | 2011-02 | INTERVENTIONAL | core: robotic vs lap hysterectomy RCT (terminated at n=3) |
| NCT01526655 | A Randomized Open Controlled Trial Comparing Robot Assisted Laparoscopic Hysterectomy and Abdominal Hysterectomy for Endometrial Cancer in a Fast Track Program | COMPLETED | NA | Endometrial Cancer | Abdominal total hysterectomy; Robot assisted laparoscopic hysterectomy | University Hospital, Linkoeping | 50 | 2012-01-25 | 2016-07-27 | INTERVENTIONAL | core: robotic vs open hysterectomy RCT (oncologic) |
| NCT01556204 | Laparoscopy vs. Robotic Surgery for Endometriosis (LAROSE): a Prospective Randomized Controlled Trial | COMPLETED | NA | Endometriosis | Robotic surgery; Laparoscopic Surgery | The Cleveland Clinic | 73 | 2012-03 | 2015-12 | INTERVENTIONAL | core: robotic vs lap endometriosis RCT (covered procedure) |
| NCT01124916 | Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies | COMPLETED | NA | Pelvic Organ Prolapse | Robotic assisted laparoscopic abdominal sacrocolpopexy; Standard laparoscopic abdominal sacrocolpopexy | Loyola University | 84 | 2009-11 | 2013-03 | INTERVENTIONAL | core: robotic vs lap sacrocolpopexy RCT (covered procedure) |
| NCT02676973 | Three Arm Apical Suspension Trial for Post-Hysterectomy Vault Prolapse | ACTIVE_NOT_RECRUITING | NA | Visceral Prolapse | Open, Robotic, or Laparoscopic; Transvaginal Native Tissue Repair; Uphold LITE | NICHD Pelvic Floor Disorders Network | 360 | 2016-02-29 | 2022-07-28 | INTERVENTIONAL | supporting: robotic arm pooled with open/lap sacral colpopexy |
| NCT03681223 | A Prospective Randomized Trial Comparing Restorelle Y Mesh vs. Vertessa Lite Y Mesh for Laparoscopic and Robotic-assisted Laparoscopic Sacrocolpopexy | COMPLETED | NA | Vaginal Vault Prolapse | Vertessa Lite Y mesh; Restorelle Y mesh; Laparoscopic sacrocolpopexy; Robotic assisted laparoscopic sacrocolpopexy | The Cleveland Clinic | 106 | 2018-09-18 | 2023-12-19 | INTERVENTIONAL | supporting: robotic sacrocolpopexy arm; mesh comparison |
| NCT02156687 | A Prospective Randomized Trial Comparing Restorelle Y Mesh vs. Restorelle Dual Flat Mesh for Laparoscopic and Robotic-assisted Laparoscopic Sacrocolpopexy | COMPLETED | NA | Prolapse | Y mesh; Dual flat mesh | The Cleveland Clinic | 59 | 2014-04-14 | 2019-11-07 | INTERVENTIONAL | supporting: robotic sacrocolpopexy arm; mesh comparison |
| NCT03815344 | A Randomized Control Trial of Combined Vaginal Misoprostol and Perivascular Vasopressin During Robotic Myomectomy | COMPLETED | PHASE4 | Leiomyoma; Laparoscopy; Uterine Myomectomy | Standard; Standard-vaginal misoprostol | Antonios Likourezos | 74 | 2017-04-26 | 2019-06-30 | INTERVENTIONAL | supporting: robotic myomectomy setting; drug comparison |
| NCT02777203 | Safety and Efficacy of Contained Electromechanical Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy | COMPLETED | NA | Leiomyoma | EcoSac 400 ECO-T | Wake Forest University Health Sciences | 60 | 2016-05 | 2019-06-30 | INTERVENTIONAL | supporting: morcellation containment in lap/robotic hysterectomy and myomectomy |
| NCT02352922 | A Randomized Controlled Trial of Wound Infiltration With Extended-release Versus Short-acting Bupivacaine Before Laparoscopic or Robotic Hysterectomy | COMPLETED | PHASE4 | Pain, Postoperative; Surgical Procedure, Unspecified | Liposomal Bupivacaine; Bupivacaine HCl | AdventHealth | 64 | 2015-07 | 2016-01 | INTERVENTIONAL | peripheral: analgesia trial in robotic hysterectomy setting |
| NCT04429022 | Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy | COMPLETED | PHASE3 | Pain, Postoperative | Gabapentin; Acetaminophen; Celecoxib; Ketorolac; Paracervical block; port-site ropivacaine; Hydromorphone; Oxycodone | State University of New York at Buffalo | 68 | 2020-11-24 | 2022-05-31 | INTERVENTIONAL | peripheral: analgesia trial in robotic hysterectomy setting |
| NCT02519023 | Transversus Abdominis Plane (TAP) Infiltration vs. Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Assisted Hysterectomy | COMPLETED | PHASE4 | Acute Pain | Liposomal Bupivacaine; Bupivacaine; Ultrasound; Epinephrine; acetaminophen; ibuprofen; Oxycodone | University of Minnesota | 87 | 2016-07 | 2017-05 | INTERVENTIONAL | peripheral: analgesia trial in lap/robotic hysterectomy setting |
| NCT02289079 | Ultrasound Guided Subcostal TAP Block With Liposomal Bupivacaine vs Bupivacaine in Robotic Hysterectomy Patients | COMPLETED | PHASE4 | Acute Pain | Bupivacaine; liposomal bupivacaine | University of Minnesota | 60 | 2013-06 | 2014-10 | INTERVENTIONAL | peripheral: analgesia trial in robotic hysterectomy setting |
| NCT03657407 | Belladonna and Opium Rectal Suppository Effect on Postoperative Pain and Nausea Following Total Laparoscopic and Robotic-Assisted Hysterectomy | COMPLETED | PHASE4 | Hysterectomy; Pain, Postoperative | Belladonna Opium; Glycerin Suppository | Anna Reinert | 56 | 2016-06-01 | 2017-05-31 | INTERVENTIONAL | peripheral: analgesia trial in lap/robotic hysterectomy setting |
| NCT02449915 | Does Liposomal Bupivacaine Improve Pain Following Robotic Sacrocolpopexy and Rectocele Repair for Pelvic Organ Prolapse? | COMPLETED | PHASE4 | Pelvic Organ Prolapse | Bupivacaine; Placebo | TriHealth Inc. | 70 | 2015-03 | 2016-08 | INTERVENTIONAL | peripheral: analgesia trial in robotic sacrocolpopexy setting |
| NCT04996251 | Clinical Effectiveness of Pre-incision Versus Post-incision Local Anesthetic During Laparoscopic/Robotic Sacrocolpopexy | COMPLETED | PHASE4 | Pain, Postoperative | Bupivacaine Injection | Northwell Health | 129 | 2021-07-30 | 2023-05-30 | INTERVENTIONAL | peripheral: analgesia trial in lap/robotic sacrocolpopexy setting |
| NCT05229653 | Postoperative Single Dose Ketamine on Pain and Recovery After Robotic Removal of Endometriosis in Patients With Chronic Pelvic Pain | TERMINATED | PHASE1 | Endometriosis; Post Operative Pain | Ketamine; Placebo | NYU Langone Health | 1 | 2022-04-12 | 2022-10-21 | INTERVENTIONAL | peripheral: analgesia trial in robotic endometriosis setting (terminated at n=1) |
| NCT03841513 | Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence | COMPLETED | NA | Pelvic Organ Prolapse; Urinary Incontinence, Stress; Urinary Incontinence, Urge; Bowel Dysfunction; Sexual Dysfunction | Laparoscopic Burch Colposuspension | Northwestern University | 50 | 2019-01-29 | 2022-09-27 | INTERVENTIONAL | peripheral: MIS prolapse setting; robotic not the intervention |
| NCT02192606 | Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? 3D Laparoscopy Versus Standard Laparoscopy | COMPLETED | NA | Uterine Fibroids; Abnormal Uterine Bleeding; Pelvic Pain; Adenomyosis | Storz 3D Laparoscopy System; 2D Laparoscopy | Brigham and Women's Hospital | 57 | 2013-11 | 2016-08 | INTERVENTIONAL | exclude on review: laparoscopic 3D vs 2D; matched on synonym expansion only |
| NCT01717521 | The Effects of Intravenous Administration of Ketamine on the Analgesia Nociception Index (ANI) Measured With the PhysioDoloris Device | COMPLETED | Monitoring, Intraoperative | University of Washington | 20 | 2012-08 | 2012-12 | OBSERVATIONAL | exclude on review: anesthesia monitoring; matched on synonym expansion only |
| ref | first author | year | title | journal | volume issue pages | doi | pmid | pmcid | verified on | verified via | role in project |
|---|---|---|---|---|---|---|---|---|---|---|---|
| L01 | Hammadeh BM | 2026 | Device-related malfunctions and associated patient harm in robotic-assisted hysterectomy: a 17-year review of the FDA MAUDE database | J Robot Surg | 20(1) | 10.1007/s11701-026-03537-9 | 42231012 | 2026-09-29 | PubMed (NLM) via connector | Nearest prior art. Descriptive, per da Vinci generation, through 2026-03-19; no product-code index, no guidance-aligned coding, no denominator. Cite prominently and differentiate. | |
| L02 | Fitzgerald AC | 2026 | Injuries associated with peritoneal entry device in laparoscopic surgery: an analysis of reports to the FDA | J Minim Invasive Gynecol | online 2026-05-17 | 10.1016/j.jmig.2026.05.009 | 42150650 | 2026-09-29 | PubMed (NLM) via connector | JMIG article within the 12-month window a JMIG Letter must respond to. Closes on 'higher quality post-market device surveillance is needed', which is the hook. | |
| L03 | Correa J | 2022 | Malfunction events in the US FDA MAUDE database: how does robotic gynecologic surgery compare with other specialties? | J Minim Invasive Gynecol | 29(2):300-307.e1 | 10.1016/j.jmig.2021.08.021 | 34464761 | 2026-09-29 | PubMed (NLM) via connector | Reporter-type finding: gyn events reported by OR staff 2.3% vs 16.1% other specialties (p=.007). Conversion to open 3.1%, lap 1.3% of malfunction events. Source for H3. | |
| L04 | Manoucheri E | 2014 | MAUDE: analysis of robotic-assisted gynecologic surgery | J Minim Invasive Gynecol | 21(4):592-595 | 10.1016/j.jmig.2013.12.122 | 24486535 | 2026-09-29 | PubMed (NLM) via connector | 2006-2012 gyn cohort; 26% injury, 8.5% death among reported events; 15 deaths during planned hysterectomy, 4 from major vessel injury with no narrative on mechanism. Motivates the emergency-access recommendation. | |
| L05 | Alemzadeh H | 2016 | Adverse events in robotic surgery: a retrospective study of 14 years of FDA data | PLoS One | 11(4):e0151470 | 10.1371/journal.pone.0151470 | 27097160 | PMC4838256 | 2026-09-29 | PubMed (NLM) via connector | 2000-2013 all-specialty NLP analysis; 10.4% of events interrupted the procedure (restart 3.1%, conversion 7.3%, reschedule 2.5%). Only prior paper with a procedure-volume denominator (manufacturer-reported). |
| L06 | Gupta P | 2017 | Development of a classification scheme for examining adverse events associated with medical devices, specifically the da Vinci Surgical System as reported in the FDA MAUDE database | J Endourol | 31(1):27-31 | 10.1089/end.2016.0396 | 27806637 | 2026-09-29 | PubMed (NLM) via connector | Severity classification with kappa 0.52 across 14 surgeons; 34% of 2009-2012 events were Ob/Gyn. Precedent for a coded schema with reported inter-rater agreement. | |
| L07 | Souders C | 2019 | Robotic sacrocolpopexy: adverse events reported to the FDA over the last decade | Int Urogynecol J | 30(11):1919-1923 | 10.1007/s00192-018-3845-6 | 30617505 | 2026-09-29 | PubMed (NLM) via connector | Prolapse-procedure MAUDE series 2007-2017 (n=334); conversions to open 5.07%, lap 1.3%, aborted 1.3% of malfunctions. Covered-procedure comparator for RQ3. | |
| L08 | Pierce H | 2021 | Patient injuries and malfunctions associated with robotic prostatectomy: review of the manufacturer and user facility device experience database | J Robot Surg | 15(2):179-185 | 10.1007/s11701-020-01088-1 | 32385798 | 2026-09-29 | PubMed (NLM) via connector | Non-gyn comparator: 13.1% of malfunctions led to an aborted case or conversion. Shows the outcome fields we propose are recoverable from narrative only by hand. |
What is not here, and why
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This page carries what the public comment states and what the snapshot computed. The manuscript's text, its figures and any result beyond the comment's headline figures appear here only after the journal article is published, and then as a link to the version of record. Every submission discloses this page.