EndoWrist 471006Recalls & reported problems
Intuitive Surgical, Inc. · LARGE NEEDLE DRIVER · Class 2
All models of EndoWrist (62)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Intuitive EndoWrist large needle driver is a robotic surgical instrument used with da Vinci systems. Of its 1,120 reports, 25 describe injuries and 1,095 describe malfunctions, with no deaths. Many reports describe parts that split, tear or fray, and some describe pieces left inside the patient. No recalls name this device.
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
- 1,115
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,115 adverse event reports that list this exact device (DI 00886874119754), received between Aug 20, 2021 and Sep 30, 2026 — classified as 26 injuries, 1,089 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (557 reports).
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
Most reported problems
Device problems
- Material Split, Cut or Torn557
- Material Frayed258
- Detachment of Device or Device Component62
- Material Fragmentation53
- Unintended System Motion48
- No Apparent Adverse Event46
- Break35
- Unintended Movement33
Patient problems
- No Clinical Signs, Symptoms or Conditions790
- Insufficient Information312
- Foreign Body In Patient9
- Bowel Perforation2
- Clinical Endoleak2
- Failure to Anastomose2
- Unspecified Tissue Injury2
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 25 most recent of 1,115 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Frayed
Patient problems: Insufficient Information
MAUDE report 50954325 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50954089 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50953700 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50953690 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926049 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925588 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925190 ↗MalfunctionSep 28, 2026Break
Patient problems: Insufficient Information
MAUDE report 50925004 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905858 ↗MalfunctionSep 25, 2026Material Frayed
Patient problems: Insufficient Information
MAUDE report 50905840 ↗MalfunctionSep 25, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905628 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905610 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904844 ↗MalfunctionSep 24, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891281 ↗MalfunctionSep 24, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891235 ↗MalfunctionSep 24, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890997 ↗MalfunctionSep 23, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875972 ↗MalfunctionSep 3, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information
MAUDE report 50579774 ↗InjurySep 1, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50541611 ↗MalfunctionAug 20, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50359509 ↗MalfunctionAug 20, 2026Material Frayed
Patient problems: Insufficient Information
MAUDE report 50337743 ↗MalfunctionAug 14, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50263501 ↗MalfunctionAug 12, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229719 ↗MalfunctionAug 12, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50229705 ↗MalfunctionAug 11, 2026Material Frayed
Patient problems: Insufficient Information
MAUDE report 50216712 ↗
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
- 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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