EndoWrist 470049Recalls & reported problems
Intuitive Surgical, Inc. · CADIERE FORCEPS · 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 Cadiere forceps is a robot-controlled surgical instrument used with da Vinci systems. The 238 reports mostly describe cables that break, fray or come loose, and in one case a wire was seen hanging out of the wrist during surgery, with the procedure finished using a backup instrument. The reports include 53 injuries and no deaths. There is 1 open recall, started in December 2024, over frayed or broken grip cables on reusable instruments.
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
- 239
- Deaths reported
- 0
- Injuries reported
- 53
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 239 adverse event reports that list this exact device (DI 00886874112250), received between Apr 25, 2017 and Sep 25, 2026 — classified as 53 injuries, 186 malfunctions.
The most frequently reported specific device problem is “Break” (106 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-0853-2025 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Break106
- Detachment of Device or Device Component79
- Material Split, Cut or Torn35
- Material Fragmentation13
- Material Frayed13
- Difficult to Open or Close7
- Detachment Of Device Component5
- Defective Component4
Patient problems
- No Clinical Signs, Symptoms or Conditions138
- No Known Impact Or Consequence To Patient65
- Insufficient Information14
- Foreign Body In Patient11
- Device Embedded In Tissue or Plaque6
- Injury2
- Bowel Perforation1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 25 most recent of 239 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905624 ↗MalfunctionSep 23, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50862957 ↗MalfunctionAug 11, 2026No Apparent Adverse Event
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: Insufficient Information
MAUDE report 50203260 ↗MalfunctionApr 14, 2026Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24878420 ↗MalfunctionApr 7, 2026Material Split, Cut or Torn
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 24810268 ↗MalfunctionFeb 26, 2026Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Insufficient Information
MAUDE report 24465861 ↗MalfunctionFeb 26, 2026Material Frayed
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CADIERE FORCEPS INSTRUMENT HAD A WIRE HANGING OUT OF THE WRIST. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY USING A BACKUP INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24465048 ↗MalfunctionFeb 25, 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 24449887 ↗MalfunctionFeb 24, 2026Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24437132 ↗MalfunctionFeb 24, 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 24425455 ↗MalfunctionFeb 23, 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 24422732 ↗MalfunctionFeb 23, 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 24422651 ↗MalfunctionFeb 23, 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 24422636 ↗MalfunctionFeb 20, 2026No Apparent Adverse Event
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 24407715 ↗MalfunctionFeb 20, 2026Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Insufficient Information
MAUDE report 24407535 ↗MalfunctionFeb 18, 2026Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Insufficient Information
MAUDE report 24374317 ↗MalfunctionFeb 14, 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 24340370 ↗MalfunctionFeb 5, 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 24273978 ↗MalfunctionJan 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 24154424 ↗MalfunctionJan 9, 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 24029705 ↗MalfunctionJan 8, 2026Material Frayed
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24014797 ↗MalfunctionDec 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO HTTPS://EMDR.FDA.GOV/EMDR/FORMINBOX/INDEX.JSF#REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23735074 ↗MalfunctionNov 27, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23668042 ↗MalfunctionNov 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23481407 ↗MalfunctionOct 31, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
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: Insufficient Information
MAUDE report 23442444 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page