EndoWrist 470230Recalls & reported problems
Intuitive Surgical, Inc. · LARGE HEM-O-LOK CLIP APPLIER · Class 2
All models of EndoWrist (62)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This da Vinci EndoWrist Large Hem-O-Lok clip applier has 1,815 adverse event reports on record, with no deaths and 61 injuries. Many reports describe clips that will not deploy, jaws that are hard to open or close, and cables that are split, frayed or loose, with a few mentioning parts entering the patient. Two open recalls name this device: one concerns frayed or broken grip cables on reusable instruments, and the other unexpected instrument motion when it partly disconnects 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
- 1,792
- Deaths reported
- 0
- Injuries reported
- 61
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1,792 adverse event reports that list this exact device (DI 00886874112380), received between Sep 5, 2018 and Sep 29, 2026 — classified as 61 injuries, 1,731 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (962 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. 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-0861-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Jul 1, 2022Class IIOpen, 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Difficult to Open or Close962
- Material Split, Cut or Torn368
- Material Frayed112
- Detachment of Device or Device Component80
- Material Fragmentation61
- Unintended System Motion61
- Break60
- No Apparent Adverse Event49
Patient problems
- No Clinical Signs, Symptoms or Conditions1,421
- Insufficient Information316
- Foreign Body In Patient36
- No Known Impact Or Consequence To Patient20
- Unspecified Tissue Injury6
- Device Embedded In Tissue or Plaque3
- Hemorrhage/Blood Loss/Bleeding3
- Fluid Discharge1
Recent adverse event reports
The 25 most recent of 1,792 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
Patient problems: Insufficient Information
MAUDE report 50939705 ↗MalfunctionSep 29, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939404 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925976 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925328 ↗MalfunctionSep 28, 2026Difficult to Open or Close
It was reported that during a da Vinci-assisted cholecystectomy surgical procedure, a Large Hem-O-Lok Clip Applier instrument would not clamp clip. The procedure was completed with no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910835 ↗MalfunctionSep 26, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906730 ↗MalfunctionSep 25, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905009 ↗MalfunctionSep 24, 2026Difficult to Open or Close
Patient problems: Insufficient Information
MAUDE report 50891434 ↗MalfunctionSep 24, 2026Difficult to Open or Close
It was reported that during a da Vinci-assisted low anterior resection (LAR) surgical procedure, the clip did not come off the 8mm Large Hem-O-Lok Clip Applier instrument. No fragment fell into the patient. No known impact or patient consequence was reported.
Patient problems: Insufficient Information
MAUDE report 50877581 ↗MalfunctionSep 23, 2026No Apparent Adverse Event
It was reported that the customer experienced an issue with a Large Hem O Lok Clip Applier instrument. There was no report of patient involvement or patient injury.
Patient problems: Insufficient Information
MAUDE report 50864102 ↗MalfunctionSep 22, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861285 ↗MalfunctionSep 17, 2026Material Split, Cut or Torn
It was reported that during a da Vinci-assisted surgical procedure, a Medium Large Clip Applier instrument had an exposed wire. The arm was broken and nonfunctional.The procedure was completed with no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797845 ↗MalfunctionSep 15, 2026Difficult to Open or Close
It was reported that during a da Vinci-assisted surgical procedure, a Large Hem-o-lok Clip Applier was not releasing the clips appropriately. There was no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50767157 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702234 ↗MalfunctionSep 2, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50575043 ↗MalfunctionSep 2, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50575011 ↗MalfunctionAug 28, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50509452 ↗MalfunctionAug 24, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50420855 ↗MalfunctionAug 14, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50254086 ↗MalfunctionAug 11, 2026No Apparent Adverse Event
Patient problems: Insufficient Information
MAUDE report 50216722 ↗MalfunctionAug 11, 2026Difficult to Open or Close
It was reported that during a da Vinci-assisted cholecystectomy surgical procedure, the 8mm Large Clip Applier would not hold the clips. The procedure was completed with no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216597 ↗MalfunctionAug 11, 2026Difficult to Open or Close
It was reported that during a da Vinci-assisted surgical procedure, 8mm Large Hem-O-Lok Clip Applier instrument works stiffly and not properly. The procedure was completed with no reported injury.Intuitive Surgical, Inc. (ISI) followed up with the site to obtain additional information, however, no further details could be provided regarding the reported event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215677 ↗MalfunctionMay 31, 2026Break
IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT TIP WAS BROKEN. THE DEVICE WAS NOT USED IN PATIENT. THERE WAS NO PATIENT HARM DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25341614 ↗MalfunctionMay 31, 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 25341543 ↗MalfunctionMay 29, 2026Difficult to Open or Close
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25339787 ↗
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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