EndoWrist 471171Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00886874121474), received between Sep 5, 2023 and Feb 25, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (6 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-0875-2025 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 24449752 ↗
• MalfunctionDec 12, 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 23796288 ↗
• MalfunctionDec 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23709649 ↗
• MalfunctionOct 30, 2025Break; Break

  IT WAS REPORTED THAT THE MARYLAND BIPOLAR FORCEPS INSTRUMENT OPEN/CLOSE PART OF THE TIP IS MISSING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT DAMAGE WAS FIRST IDENTIFIED DURING POST-CLEANING INSPECTION AFTER STERILIZATION. THE SURGEON DID NOT COMMENT ON THE CAUSE SINCE NO FRAGMENT FELL AND NOTED NO FUNCTIONAL ISSUES DURING SURGERY. THERE WAS NO PATIENT INJURY. THE BREAKAGE LIKELY OCCURRED WHILE THE INSTRUMENT WAS INSIDE THE PATIENT'S ANATOMY, HOWEVER NO FRAGMENT WAS CONFIRMED INSIDE PATIENT'S ANATOMY AND NO INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23421483 ↗
• MalfunctionMay 7, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM MICRO BIPOLAR FORCEPS INSTRUMENT HAD A BROKEN WIRE. NO FRAGMENTS FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21980902 ↗
• MalfunctionApr 24, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CARDIAC SURGICAL PROCEDURE, AT THE END OF THE SURGICAL PROCEDURE, THE STEEL CABLE AT THE TIP OF THE MICRO BIPOLAR FORCEPS JOINT CAME LOOSE COMPLETELY. AS IT WAS AT THE END OF THE SURGERY, IT WAS NOT NECESSARY TO USE ANOTHER CLAMP. INSTRUMENT HAVE 10 LIVES REMAINING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CLARIFIED THAT THE DAMAGE TO THE MATERIAL WAS IDENTIFIED OUTSIDE THE PATIENT, DURING THE CHANGE OF CLAMPS, I.E. OUTSIDE THE SURGICAL FIELD AND NOT DURING DIRECT USE ON THE PATIENT. THERE WERE NO REPORTS OF FRAGMENTS FALLING FROM THE DEVICE DURING USE ON THE PATIENT, NOR ANY INJURY OR COMPLICATION RELATED TO THE RETENTION OF MATERIAL. THERE WAS ALSO NO NEED FOR THE PATIENT TO RETURN TO HOSPITAL FOR THIS REASON.

  Patient problems: Insufficient Information

  MAUDE report 21904624 ↗
• MalfunctionApr 2, 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 21757141 ↗
• MalfunctionJun 27, 2024Thermal Decomposition of Device; Material Twisted/Bent; Material Split, Cut or Torn; Thermal Decomposition of Device; Material Twisted/Bent; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TEETH OF THE MICRO BIPOLAR FORCEPS INSTRUMENT DID NOT MATCH. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19630458 ↗
• MalfunctionDec 22, 2023Thermal Decomposition of Device; Energy Output Problem; Material Split, Cut or Torn; Thermal Decomposition of Device; Energy Output Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MICRO BIPOLAR FORCEPS INSTRUMENT WAS NOT DELIVERING ENERGY CONSISTENTLY AND NOT CAUTERIZING. 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 CUSTOMER NOTED NO THERMAL DAMAGE WAS OBSERVED. NO ARCING WAS OBSERVED DURING THE PROCEDURE. NO SPARKING, SMOKE OCCURRED DURING PROCEDURE. NO PATIENT INJURY OR ADVERSE EVENT DURING OR AFTER SURGICAL PROCEDURE. IT IS UNSURE IF THERE ARE ANY PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE AVAILABLE FOR ISI REVIEW. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE OR ANYTHING OUT OF THE ORDINARY. THERE WAS NO THERMAL DAMAGE OBSERVED. TO THEIR KNOWLEDGE, THERE WAS NO INSTRUMENT COLLISION WITH AN ENERGY INSTRUMENT DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18381280 ↗
• MalfunctionSep 5, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE MICRO BIPOLAR FORCEPS INSTRUMENT TIP (YELLOWISH PART) LOOKED MELTED OFF. THE INSTRUMENT WAS NEVER USED FOR A CASE JUST IN CASE THE MELTED PART HAS ROUGH EDGES THAT MAY HURT THE PATIENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686521 ↗