EndoWrist 471405Recalls & reported problems
Intuitive Surgical, Inc. · FORCE BIPOLAR · Class 2
All models of EndoWrist (62)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Intuitive da Vinci Force Bipolar instrument is a surgical tool used in robotic surgery. Many reports describe cables that are frayed, torn or broken, and some describe parts of the tool breaking or detaching, with some mentioning a part left inside the patient. The 3,818 reports include 1 death and 326 injuries. There is 1 open recall, started in December 2024, over frayed or broken grip cables on instruments with jaws.
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
- 3,770
- Deaths reported
- 1
- Injuries reported
- 324
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3,770 adverse event reports that list this exact device (DI 00886874120767), received between Dec 6, 2020 and Sep 30, 2026 — classified as 1 death, 324 injuries, 3,445 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (1,204 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-0883-2025 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Split, Cut or Torn1,204
- Material Frayed475
- Break413
- Detachment of Device or Device Component389
- Difficult to Open or Close295
- Difficult to Remove219
- Material Fragmentation185
- Entrapment of Device159
Patient problems
- No Clinical Signs, Symptoms or Conditions2,824
- Insufficient Information746
- Unspecified Tissue Injury119
- Foreign Body In Patient84
- Hemorrhage/Blood Loss/Bleeding26
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Bowel Perforation1
- Burn(s)1
Recent adverse event reports
The 25 most recent of 3,770 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954061 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953895 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953752 ↗MalfunctionSep 30, 2026Unintended Movement
It was reported that during a da Vinci-assisted surgical procedure, the 8mm Force Bipolar instrument could not be rotated properly.The procedure was completed with no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949279 ↗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: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942407 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939712 ↗MalfunctionSep 29, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939410 ↗MalfunctionSep 28, 2026Material Frayed
Patient problems: Insufficient Information
MAUDE report 50925605 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50925342 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924983 ↗MalfunctionSep 26, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906733 ↗MalfunctionSep 26, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906729 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905843 ↗MalfunctionSep 25, 2026Material Frayed
Patient problems: Insufficient Information
MAUDE report 50905798 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50905795 ↗MalfunctionSep 25, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905761 ↗MalfunctionSep 25, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905746 ↗MalfunctionSep 25, 2026Break
Patient problems: Insufficient Information
MAUDE report 50905525 ↗MalfunctionSep 25, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905509 ↗MalfunctionSep 25, 2026Material Frayed
Patient problems: Insufficient Information
MAUDE report 50905020 ↗MalfunctionSep 25, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904712 ↗MalfunctionSep 25, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904526 ↗MalfunctionSep 25, 2026Material Twisted/Bent
It was reported that prior to the start of a da Vinci-assisted surgical procedure, the 8mm Force Bipolar instrument tips were not aligned. The procedure was completed with no reported injury.Intuitive Surgical, Inc. (ISI) followed up with the initial reporter and obtained the following additional information: No arcing was observed during the last procedure in which the instrument was used. There was no injury to the patient as instrument was not used on patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893641 ↗MalfunctionSep 25, 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 50893638 ↗MalfunctionSep 24, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891231 ↗
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 470327Intuitive Surgical, Inc. · System,surgical,computer controlled instrument2 recalls2,273 reports
- None 480275Intuitive Surgical, Inc. · System,surgical,computer controlled instrument1 death2,324 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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