EndoWrist 470205Recalls & reported problems
Intuitive Surgical, Inc. · FENESTRATED BIPOLAR FORCEPS · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Intuitive EndoWrist forceps is a reusable instrument for da Vinci surgical robots. Many reports describe the instrument material splitting, tearing or breaking, and some mention imprecise motion. The records include 1,955 reports, 45 injuries and no deaths. There is 1 recall, open since December 2024, over frayed or broken grip cables on reusable instruments with jaws. Reports fell from 1,065 in the year before to 436 in the most recent year.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,955
- Deaths reported
- 0
- Injuries reported
- 45
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,955 adverse event reports that list this exact device (DI 00886874112359), received between Dec 27, 2016 and Sep 30, 2026 — classified as 45 injuries, 1,910 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (1,444 reports).
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0859-2025 · Root cause: Process change control · FDA record ↗
Most reported problems
Device problems
- Material Split, Cut or Torn1,444
- Break133
- Thermal Decomposition of Device82
- Material Fragmentation59
- Material Frayed55
- Detachment of Device or Device Component46
- Failure to Deliver Energy40
- Arcing38
Patient problems
- No Clinical Signs, Symptoms or Conditions1,672
- Insufficient Information153
- No Known Impact Or Consequence To Patient81
- Device Embedded In Tissue or Plaque23
- Foreign Body In Patient18
- No Patient Involvement5
- Unspecified Tissue Injury4
- Burn(s)2
Recent adverse event reports
The 25 most recent of 1,955 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50953173 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
It was reported that there was a broken cable with a da Vinci product. The customer reported event has no report of patient injury.
Patient problems: Insufficient Information
MAUDE report 50942364 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925500 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925183 ↗MalfunctionSep 24, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50891228 ↗MalfunctionAug 12, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50229721 ↗MalfunctionMay 27, 2026Unintended Movement
IT WAS REPORTED THAT THERE WAS A LIMITED/IMPRECISE MOTION ISSUE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25308230 ↗MalfunctionMay 27, 2026Unintended Movement
IT WAS REPORTED THAT THERE WAS A LIMITED/IMPRECISE MOTION ISSUE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25308222 ↗MalfunctionMay 27, 2026Unintended Movement
IT WAS REPORTED THAT THERE WAS A LIMITED/IMPRECISE MOTION ISSUE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25308220 ↗MalfunctionMay 27, 2026Unintended Movement
IT WAS REPORTED THAT THERE WAS A LIMITED/IMPRECISE MOTION ISSUE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25308214 ↗MalfunctionMay 27, 2026Unintended Movement
IT WAS REPORTED THAT THERE WAS A LIMITED/IMPRECISE MOTION ISSUE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25308212 ↗MalfunctionMay 27, 2026Unintended Movement
IT WAS REPORTED THAT THERE WAS A LIMITED/IMPRECISE MOTION ISSUE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25308208 ↗MalfunctionMay 27, 2026Unintended Movement
IT WAS REPORTED THAT THERE WAS A LIMITED/IMPRECISE MOTION ISSUE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25308203 ↗MalfunctionMay 22, 2026No Device Output; Device Dislodged or Dislocated; Material Split, Cut or Torn
IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT COULD NOT BE USED AFTER BEING INSTALLED ON THE SYSTEM. THE PROCEDURE WAS ABORTED. NO PATIENT INVOLVEMENT WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25262573 ↗MalfunctionMay 21, 2026Unintended Movement
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 25249197 ↗MalfunctionMay 7, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 25108424 ↗MalfunctionMay 6, 2026Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25090184 ↗MalfunctionMay 6, 2026Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25090177 ↗MalfunctionMay 6, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25090175 ↗MalfunctionMay 1, 2026Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25054187 ↗MalfunctionMay 1, 2026Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25054183 ↗MalfunctionApr 29, 2026Thermal Decomposition of Device; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS FOUND TO HAVE A DAMAGED TIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25036970 ↗MalfunctionApr 24, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24990503 ↗MalfunctionApr 22, 2026Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24960212 ↗MalfunctionApr 18, 2026Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24919074 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.