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EndoWrist 471049Recalls & reported problems

Intuitive Surgical, Inc. · CADIERE 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 Cadiere forceps is a surgical instrument used with da Vinci robots. Its 2,270 reports often describe the instrument material splitting, tearing or fraying, and mention 79 injuries and 1 death. One recall, started in December 2024 and open, 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
2,253
Deaths reported
1
Injuries reported
79
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2,253 adverse event reports that list this exact device (DI 00886874119778), received between Dec 10, 2020 and Sep 30, 2026 — classified as 1 death, 79 injuries, 2,173 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1,297 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

Nov 2023: 2 reportsDec 2023: 1 reportsJan 2024: 11 reportsFeb 2024: 1 reportsMar 2024: 6 reportsApr 2024: 4 reportsMay 2024: 4 reportsJun 2024: 5 reportsJul 2024: 6 reportsAug 2024: 2 reportsSep 2024: 3 reportsOct 2024: 8 reportsNov 2024: 4 reportsDec 2024: 4 reportsJan 2025: 1 reportsFeb 2025: 7 reportsMar 2025: 180 reportsApr 2025: 93 reportsMay 2025: 129 reportsJun 2025: 161 reportsJul 2025: 146 reportsAug 2025: 122 reportsSep 2025: 92 reportsOct 2025: 93 reportsNov 2025: 155 reportsDec 2025: 135 reportsJan 2026: 123 reportsFeb 2026: 260 reportsMar 2026: 165 reportsApr 2026: 109 reportsMay 2026: 47 reportsJun 2026: 0 reportsJul 2026: 2 reportsAug 2026: 21 reportsSep 2026: 22 reportsOct 2026: 0 reports202420252026260
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Dec 19, 2024Open, Classified

    Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

    Z-0873-2025 · Root cause: Process change control · FDA record ↗

Most reported problems

Device problems

  • Material Split, Cut or Torn1,297
  • Material Frayed455
  • Detachment of Device or Device Component122
  • Material Fragmentation89
  • Break88
  • No Apparent Adverse Event72
  • Unintended Movement48
  • Unintended System Motion28

Patient problems

  • No Clinical Signs, Symptoms or Conditions1,596
  • Insufficient Information625
  • Unspecified Tissue Injury16
  • Foreign Body In Patient13
  • Hemorrhage/Blood Loss/Bleeding9
  • Bowel Perforation1
  • Burn(s)1
  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

The 25 most recent of 2,253 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 50953295 ↗
  • MalfunctionSep 30, 2026Unintended Movement

    It was reported that after a da Vinci-assisted surgical procedure, a Cadiere Forceps instrument was observed not being manipulated. The procedure was completed with no reported injury.Intuitive Surgical followed up with the initial reporter and obtained the following additional information: No fragment falling into the patient. No fragments retrieved from the patient, nor patient returned to hospital experiencing any post-surgical complications.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50942435 ↗
  • MalfunctionSep 30, 2026Difficult to Open or Close

    It was reported that there was a limited or imprecise motion issue with a da Vinci product. The customer reported event has no report of patient injury.

    Patient problems: Insufficient Information

    MAUDE report 50942406 ↗
  • MalfunctionSep 29, 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 50928026 ↗
  • MalfunctionSep 28, 2026Material Frayed

    Patient problems: Insufficient Information

    MAUDE report 50926098 ↗
  • MalfunctionSep 28, 2026Material Frayed; Appropriate Device Problem Term/Code Not Available

    Patient problems: Insufficient Information

    MAUDE report 50926096 ↗
  • MalfunctionSep 28, 2026Material Frayed

    Patient problems: Insufficient Information

    MAUDE report 50926092 ↗
  • MalfunctionSep 28, 2026Material Split, Cut or Torn

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50925596 ↗
  • MalfunctionSep 28, 2026Material Split, Cut or Torn

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50925526 ↗
  • MalfunctionSep 28, 2026Material Split, Cut or Torn

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50925012 ↗
  • MalfunctionSep 26, 2026Material Fragmentation

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50906724 ↗
  • MalfunctionSep 25, 2026No Device Output

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50905852 ↗
  • MalfunctionSep 25, 2026Material Frayed

    Patient problems: Insufficient Information

    MAUDE report 50905786 ↗
  • MalfunctionSep 25, 2026Material Split, Cut or Torn

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50905619 ↗
  • MalfunctionSep 25, 2026Material Split, Cut or Torn

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50904913 ↗
  • MalfunctionSep 25, 2026Material Split, Cut or Torn

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50904511 ↗
  • 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.A review of the provided image is consistent with broken cable.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50893634 ↗
  • MalfunctionSep 24, 2026Material Split, Cut or Torn

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50891547 ↗
  • MalfunctionSep 24, 2026Material Split, Cut or Torn

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50890800 ↗
  • MalfunctionSep 23, 2026No Apparent Adverse Event

    Patient problems: Insufficient Information

    MAUDE report 50875926 ↗
  • MalfunctionSep 23, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50874924 ↗
  • MalfunctionSep 22, 2026Material Frayed

    It was reported that there was a frayed 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 50850392 ↗
  • MalfunctionAug 20, 2026Material Frayed

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50359544 ↗
  • MalfunctionAug 20, 2026Material Split, Cut or Torn

    Patient problems: Insufficient Information

    MAUDE report 50357807 ↗
  • MalfunctionAug 20, 2026Material Split, Cut or Torn

    Patient problems: Insufficient Information

    MAUDE report 50357805 ↗

Other System, surgical, computer controlled instrument devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.