EndoWrist 471093Recalls & reported problems
Intuitive Surgical, Inc. · PROGRASP FORCEPS · 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 EndoWrist ProGrasp forceps for da Vinci systems appears in 8,631 adverse event reports, including 171 injuries and no deaths. The reports mostly describe frayed, torn or broken cables and parts that split or fragment. One open recall, from December 2024, concerns frayed or broken grip cables on reusable 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
- 8,581
- Deaths reported
- 0
- Injuries reported
- 173
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 8,581 adverse event reports that list this exact device (DI 00886874119785), received between Dec 10, 2020 and Sep 30, 2026 — classified as 173 injuries, 8,408 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (4,852 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-0874-2025 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Split, Cut or Torn4,852
- Material Frayed1,829
- Material Fragmentation572
- Detachment of Device or Device Component394
- No Apparent Adverse Event289
- Break187
- Unintended Movement172
- Unintended System Motion97
Patient problems
- No Clinical Signs, Symptoms or Conditions6,312
- Insufficient Information2,191
- Foreign Body In Patient67
- Unspecified Tissue Injury25
- Hemorrhage/Blood Loss/Bleeding5
- Bowel Perforation2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bruise/Contusion1
Recent adverse event reports
The 25 most recent of 8,581 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954554 ↗MalfunctionSep 30, 2026Entrapment of Device; Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954548 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954386 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50954331 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954322 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954317 ↗MalfunctionSep 30, 2026Material Frayed
Patient problems: Insufficient Information
MAUDE report 50954308 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50954304 ↗MalfunctionSep 30, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953290 ↗MalfunctionSep 30, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949834 ↗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 50942365 ↗MalfunctionSep 29, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939696 ↗MalfunctionSep 29, 2026Material Frayed
Patient problems: Insufficient Information
MAUDE report 50926986 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926099 ↗MalfunctionSep 28, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926048 ↗MalfunctionSep 28, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925982 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50925336 ↗MalfunctionSep 28, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925036 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925023 ↗MalfunctionSep 28, 2026Material Twisted/Bent
Patient problems: Insufficient Information
MAUDE report 50924713 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50905849 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50905839 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905832 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905800 ↗MalfunctionSep 25, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information
MAUDE report 50905762 ↗
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 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
- 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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