EndoWrist;daVinci Si 420177Recalls & reported problems
Intuitive Surgical, Inc. · BOWEL GRASPER · Class 2
All models of EndoWrist;daVinci Si (35)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886874111482), received between Dec 16, 2020 and Dec 16, 2020 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AS THE SURGEON GRASPED THEN RELEASED THE PATIENT¿S BOWEL WITH A BOWEL GRASPER INSTRUMENT, THE BOWEL ¿TORE¿. THE SURGEON REPAIRED THE BOWEL WITH AN UNDISCLOSED AMOUNT OF SUTURES. A BACKUP BOWEL GRASPER INSTRUMENT WAS INSTALLED. THE PROCEDURE COMPLETED WITH NO CUSTOMER REPORTED INJURY. ON 25-NOV-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE CONSOLE SURGEON REGARDING THE REPORTED EVENT: DURING A DA VINCI-ASSISTED REVISIONAL GASTRIC BYPASS PROCEDURE, THE SURGEON WAS, ¿RUNNING THE BOWEL WITH TWO GRASPERS¿ AND THE, ¿ONE IN RIGHT HAND TORE THE BOWEL¿. THE SURGEON IMMEDIATELY APPLIED A BACKUP BOWEL GRASPER INSTRUMENT AND APPLIED FOUR VICRYL SUTURES TO REPAIR THE BOWEL INTRA-OPERATIVELY. THERE WAS NO ADDITIONAL UNEXPECTED BLEEDING AND NO OTHER INTRA-OPERATIVE COMPLICATIONS. THE PROCEDURE COMPLETED ROBOTICALLY WITH THE USE OF A BACKUP BOWEL GRASPER INSTRUMENT AND NO REPORTED PATIENT INJURY. THERE HAVE BEEN NO REPORTS OF POST-OPERATIVE COMPLICATIONS AND THE PATIENT WAS REPORTED AS DOING FINE. THE FEMALE PATIENT HAD A BMI OF 44 AND PRIOR BARIATRIC SURGERY. THE SURGEON ATT
Patient problems: Injury
MAUDE report 11021505 ↗
Other System,surgical,computer controlled instrument devices
- EndoWrist 471205Intuitive Surgical, Inc. · System, surgical, computer controlled instrument1 recall14,225 reports
- EndoWrist 470179Intuitive Surgical, Inc. · System,surgical,computer controlled instrument2 recalls2 deaths10,156 reports
- EndoWrist 471093Intuitive Surgical, Inc. · System, surgical, computer controlled instrument1 recall8,581 reports
- EndoWrist 471172Intuitive Surgical, Inc. · System, surgical, computer controlled instrument1 recall1 death6,302 reports
- daVinci Xi 380652Intuitive Surgical, Inc. · System,surgical,computer controlled instrument2 recalls235 deaths5,316 reports
- daVinci Xi 381121Intuitive Surgical, Inc. · System,surgical,computer controlled instrument1 recall2 deaths4,310 reports
- EndoWrist 471405Intuitive Surgical, Inc. · System, surgical, computer controlled instrument1 recall1 death3,770 reports
- EndoWrist 470327Intuitive Surgical, Inc. · System,surgical,computer controlled instrument2 recalls2,273 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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