EndoWrist 470327Recalls & reported problems
Intuitive Surgical, Inc. · MEDIUM-LARGE CLIP APPLIER · Class 2
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Intuitive EndoWrist medium-large clip applier is a surgical instrument used with da Vinci robots. Its 2,291 reports often describe the jaws being hard to open or close, and some describe clips that would not release and an artery tearing during surgery. They mention 132 injuries and no deaths. Two open recalls cover frayed or broken grip cables on reusable instruments and unexpected motion when the instrument partly disengages from the system.
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
- 2,273
- Deaths reported
- 0
- Injuries reported
- 130
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 2,273 adverse event reports that list this exact device (DI 00886874112465), received between Jul 9, 2018 and Sep 30, 2026 — classified as 130 injuries, 2,142 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (1,635 reports).
2 FDA recall records name this device's identifier, 2 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
Recalls naming this device
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0867-2025 · Root cause: Process change control · FDA record ↗
- Jul 1, 2022Open, Classified
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
Z-1460-2022 · Root cause: Nonconforming Material/Component · FDA record ↗
Most reported problems
Device problems
- Difficult to Open or Close1,635
- Material Split, Cut or Torn177
- Detachment of Device or Device Component99
- Unintended System Motion83
- Material Frayed67
- Unintended Movement57
- Material Twisted/Bent55
- No Apparent Adverse Event38
Patient problems
- No Clinical Signs, Symptoms or Conditions1,866
- Insufficient Information320
- Foreign Body In Patient57
- Hemorrhage/Blood Loss/Bleeding16
- No Known Impact Or Consequence To Patient15
- Unspecified Tissue Injury10
- Cardiac Arrest1
- Laceration(s)1
Recent adverse event reports
The 25 most recent of 2,273 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Difficult to Open or Close
Patient problems: Insufficient Information
MAUDE report 50954544 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50954310 ↗MalfunctionSep 30, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953749 ↗MalfunctionSep 30, 2026Premature End-of-Life Indicator; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953599 ↗MalfunctionSep 30, 2026Difficult to Open or Close
It was reported that during a da Vinci-assisted surgical procedure, the 8mm Medium-Large Clip Applier instrument will not close the clip completely. The user completed the procedure with no further issue reported. No fragment fell inside the patient. No known impact or patient consequence was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942429 ↗MalfunctionSep 30, 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 50942381 ↗MalfunctionSep 29, 2026Device Difficult to Setup or Prepare; Material Twisted/Bent
Patient problems: Insufficient Information
MAUDE report 50939242 ↗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: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928028 ↗MalfunctionSep 28, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926102 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925604 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50925495 ↗MalfunctionSep 28, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925355 ↗MalfunctionSep 28, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925346 ↗MalfunctionSep 28, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925329 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925057 ↗MalfunctionSep 28, 2026Difficult to Open or Close
It was reported that during a da Vinci-assisted surgical procedure, the tip of a Medium-Large Clip Applier instrument would not hold clip. The procedure was completed with no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910831 ↗MalfunctionSep 26, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906725 ↗MalfunctionSep 26, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906719 ↗MalfunctionSep 25, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905855 ↗MalfunctionSep 25, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905845 ↗MalfunctionSep 25, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905827 ↗MalfunctionSep 25, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905626 ↗MalfunctionSep 25, 2026Device Difficult to Setup or Prepare
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905506 ↗MalfunctionSep 25, 2026Difficult to Open or Close
Patient problems: Insufficient Information
MAUDE report 50905021 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904895 ↗
Other System,surgical,computer controlled instrument devices
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- 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
- None 480275Intuitive Surgical, Inc. · System,surgical,computer controlled instrument1 death2,324 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.