EndoWrist 470194Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,043 adverse event reports that list this exact device (DI 00886874112342), received between Jun 1, 2017 and Sep 30, 2026 — classified as 16 injuries, 1,027 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (620 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 16, 2026.

Recalls naming this device

1. Dec 19, 2024Open, Classified

   Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

   Z-0858-2025 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,043 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954073 ↗
• MalfunctionSep 30, 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.Review of the provided image is consistent with broken cable. Root cause of the failure mode cannot be confirmed without the returned device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942380 ↗
• MalfunctionSep 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905317 ↗
• MalfunctionSep 25, 2026Material Split, Cut or Torn

  It was reported that the Mega Needle Driver instrument had a broke tip. The procedure was completed with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893577 ↗
• MalfunctionSep 23, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50875949 ↗
• MalfunctionSep 23, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874586 ↗
• 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: Insufficient Information

  MAUDE report 50856395 ↗
• MalfunctionAug 24, 2026Material Split, Cut or Torn

  Patient problems: Insufficient Information

  MAUDE report 50420624 ↗
• MalfunctionAug 20, 2026Material Split, Cut or Torn

  Patient problems: Insufficient Information

  MAUDE report 50359548 ↗
• MalfunctionAug 14, 2026Material Frayed; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254120 ↗
• 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216717 ↗
• MalfunctionAug 7, 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 50184397 ↗
• MalfunctionMay 28, 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 25324997 ↗
• MalfunctionMay 20, 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: Insufficient Information

  MAUDE report 25235316 ↗
• MalfunctionMay 18, 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 25196983 ↗
• MalfunctionMay 15, 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 25179975 ↗
• MalfunctionMay 14, 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 25178169 ↗
• MalfunctionMay 12, 2026Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE JAWS OF A MEGA NEEDLE DRIVER INSTRUMENT WERE MISALIGNED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO FRAGMENTS FELL INTO PATIENT'S ANATOMY. THE DAMAGE TO THE INSTRUMENT OCCURRED OUTSIDE OF A SURGICAL PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 25155498 ↗
• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS ARE AVAILABLE REGARDING THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 25143853 ↗
• MalfunctionMay 9, 2026Break

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25131709 ↗
• MalfunctionMay 7, 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: Insufficient Information

  MAUDE report 25118773 ↗
• MalfunctionMay 6, 2026Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE MEGA NEEDLE DRIVER INSTRUMENT WAS GOING THE OPPOSITE WAY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO PATIENT INJURY OR VISIBLE DAMAGE TO THE INSTRUMENT, INCLUDING JAWS, TIPS, OR CABLES, WAS REPORTED. THE ISSUE WAS RESOLVED BY REPLACING THE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107432 ↗
• MalfunctionMay 6, 2026Material Split, Cut or Torn

  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 25107307 ↗
• MalfunctionMay 4, 2026Material Integrity Problem

  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 25074310 ↗
• MalfunctionApr 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 25029375 ↗