EndoWrist 471309Recalls & reported problems
Intuitive Surgical, Inc. · MEGA SUTURECUT ND · Class 2
All models of EndoWrist (62)
Data updated Oct 18, 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 Mega SutureCut is a surgical needle driver used with da Vinci robots. Its 2,256 reports often describe the instrument splitting, tearing or fragmenting, and some mention fragments left in patients. They mention 102 injuries and no deaths. 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
- 2,244
- Deaths reported
- 0
- Injuries reported
- 102
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2,244 adverse event reports that list this exact device (DI 00886874119815), received between Dec 15, 2020 and Sep 30, 2026 — classified as 102 injuries, 2,142 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (850 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 18, 2026.
Reports received per month
Recalls naming this device
- Dec 19, 2024Class IIOpen, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0880-2025 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Split, Cut or Torn850
- Material Fragmentation657
- Material Frayed301
- Detachment of Device or Device Component136
- Break112
- No Apparent Adverse Event61
- Unintended System Motion47
- Unintended Movement41
Patient problems
- No Clinical Signs, Symptoms or Conditions1,640
- Insufficient Information568
- Foreign Body In Patient42
- No Known Impact Or Consequence To Patient1
- Unspecified Tissue Injury1
Recent adverse event reports
The 25 most recent of 2,244 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953694 ↗MalfunctionSep 29, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939789 ↗MalfunctionSep 28, 2026Unintended Movement
Patient problems: Insufficient Information
MAUDE report 50926017 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925948 ↗MalfunctionSep 26, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906714 ↗MalfunctionSep 25, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905033 ↗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 50893581 ↗MalfunctionSep 24, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891292 ↗MalfunctionSep 23, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875903 ↗MalfunctionSep 23, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875189 ↗MalfunctionSep 23, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50875040 ↗MalfunctionSep 23, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50874925 ↗MalfunctionSep 22, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861042 ↗MalfunctionSep 22, 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 50850389 ↗MalfunctionSep 15, 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: Insufficient Information
MAUDE report 50767089 ↗MalfunctionSep 5, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50626874 ↗MalfunctionSep 2, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50575235 ↗MalfunctionAug 27, 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 50468083 ↗MalfunctionAug 24, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50420621 ↗MalfunctionAug 20, 2026Material Frayed
Patient problems: Insufficient Information
MAUDE report 50359529 ↗MalfunctionAug 19, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50332492 ↗MalfunctionAug 19, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50315237 ↗MalfunctionAug 13, 2026Break
Patient problems: Insufficient Information
MAUDE report 50243895 ↗MalfunctionAug 13, 2026Break
Patient problems: Insufficient Information
MAUDE report 50231274 ↗MalfunctionAug 11, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216688 ↗
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 · each recall links to the FDA recall notice
- 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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