EndoWrist 470033Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00886874112229), received between Aug 31, 2023 and Aug 11, 2026 — classified as 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (10 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 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-0852-2025 · Root cause: Process change control · Recall details · FDA record ↗

2. Dec 19, 2024Open, Classified

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

   Z-0851-2025 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• 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. 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: Insufficient Information

  MAUDE report 50216263 ↗
• 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 25197041 ↗
• MalfunctionApr 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 24949143 ↗
• MalfunctionFeb 26, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE 8MM BLACK DIAMOND MICRO FORCEPS INSTRUMENT HAD AN ISSUE. NO FURTHER INFORMATION WAS PROVIDED. 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: Insufficient Information

  MAUDE report 24464623 ↗
• MalfunctionFeb 17, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM BLACK DIAMOND MICRO FORCEPS INSTRUMENT WAS NOT OPENING SLIPPING GRIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24372180 ↗
• MalfunctionFeb 2, 2026Material Frayed

  IT WAS REPORTED THAT THE 8MM BLACK DIAMOND MICRO FORCEPS INSTRUMENT WAS DEFECTIVE.

  Patient problems: Insufficient Information

  MAUDE report 24242283 ↗
• MalfunctionJan 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 24216967 ↗
• MalfunctionJan 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 24170436 ↗
• MalfunctionJan 5, 2026Unintended Movement

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23965236 ↗
• MalfunctionDec 5, 2025Material Frayed; Material 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 23734115 ↗
• InjuryDec 3, 2025Detachment of Device or Device Component; Difficult to Open or Close; Detachment of Device or Device Component; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THE JAWS OF THE BLACK DIAMOND MICRO FORCEPS INSTRUMENT DID NOT CLOSE PROPERLY DUE TO MISALIGNED TIPS AND A NEEDLE DROPPED INSIDE THE PATIENT AS A RESULT OF THE FAILURE. THE NEEDLE WAS RETRIEVED DURING THE SAME PROCEDURE WITH ANOTHER DA VINCI INSTRUMENT. NO PIECES FROM THE DISTAL END OF THE INSTRUMENT DETACHED/BROKE OFF. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE NEEDLE. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706748 ↗
• MalfunctionSep 17, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23079827 ↗
• MalfunctionAug 29, 2025Material Frayed; Material Frayed

  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 22928820 ↗
• MalfunctionJul 23, 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 22581400 ↗
• MalfunctionJul 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM BLACK DIAMON MICRO FORCEPS INSTRUMENT WAS OBSERVED TO HAVE A BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. THERE WERE NO REPORTS OF FRAGMENT(S) FALLING INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22515137 ↗
• MalfunctionJul 1, 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 REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22377067 ↗
• MalfunctionJun 25, 2025Material Frayed; Material 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 22332534 ↗
• MalfunctionMay 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  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 22074060 ↗
• MalfunctionMay 21, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22065587 ↗
• MalfunctionJan 16, 2025Material Fragmentation; Material Fragmentation

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21165323 ↗
• MalfunctionJan 14, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CABLE OF BLACK DIAMOND MICRO FORCEPS INSTRUMENT HAD SNAPPED OUT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE BLACK DIAMOND MICRO FORCEPS INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE TO BE NOTED. SURGEON WAS SUTURING WHEN ISSUE OCCURRED. THE WERE NO ISSUES WITH OPENING / CLOSING OF THE GRIPS; LEFT / RIGHT (YAW) MOTION OF THE GRIPS OR UP/DOWN (PITCH) MOTION OF WRIST BEFORE THE WIRES BROKE. THERE WERE NO CABLES VISIBLY PROTRUDING FROM THE DISTAL END OF THE INSTRUMENT. NO FRAGMENTS FELL INTO THE PATIENT. INSTRUMENT WAS RETURNED FOR ISI EVALUATION. NO PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE WERE AVAILABLE FOR ISI REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21146694 ↗
• MalfunctionJan 9, 2025Material Fragmentation; Material Frayed; Material Fragmentation; Material Frayed

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A WIRE WAS BROKEN ON A BLACK DIAMOND MICRO FORCEPS INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21109046 ↗
• MalfunctionAug 15, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SINGLE VESSEL TECAB SURGICAL PROCEDURE, THE 8MM BLACK DIAMOND MICRO FORCEPS INSTRUMENT HAD A BROKEN CABLE. THE CABLE GOT CUT. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS BEING USED TO DISSECT TISSUE WHEN THE ISSUE OCCURRED. THERE WAS NO INSTRUMENT COLLISION. THE ISSUE WAS NOT RELATED TO THE OPENING/CLOSING OF THE INSTRUMENT BUT THE INSTRUMENT CABLE SNAPPED WHEN THE INSTRUMENT WAS ROTATED. THERE WAS NO ISSUE WITH THE HORIZONTAL OR VERTICAL MOTION OF THE GRIPS/WRIST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19988919 ↗
• MalfunctionJul 16, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED DURING CENTRAL PROCESSING, BLACK DIMOND MICRO FORCEPS INSTRUMENT WAS NOT RESPONDING TO MANIPULATION OF HAND CONTROLS PROPERLY. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19756791 ↗
• MalfunctionJul 11, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TUBAL REANASTOMOSIS SURGICAL PROCEDURE, AN UNCONTROLLED MOTION WAS NOTED ON THE BLACK DIAMOND MICRO FORCEPS INSTRUMENT. THE INSTRUMENT DID NOT WORK CORRECTLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND OBTAINED ADDITIONAL INFORMATION REGARDING THIS EVENT: THE ISSUE DID NOT OCCUR WITH THE SURGEON'S HEAD INSIDE THE SURGEON CONSOLE'S HIGH-RESOLUTION STEREO VIEWER. THE ISSUE OCCURRED WHILE THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SURGEON'S CONSOLE. THE TIMING OF INSTRUMENT MOVEMENT WAS APPROPRIATE. THE ACTION BEING TAKEN AND/OR INTENDED WHEN THE ISSUE OCCURRED WAS A CHANGE OF INSTRUMENT. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE EVENT. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19725658 ↗