EndoWrist 470171Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00886874112274), received between Feb 28, 2021 and Jul 22, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 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-0855-2025 · Root cause: Process change control · 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.

• MalfunctionJul 22, 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: Insufficient Information

  MAUDE report 22570494 ↗
• MalfunctionApr 4, 2025Break; Break

  IT WAS REPORTED THAT 8MM MICRO BIPOLAR FORCEPS INSTRUMENT SEAM IN PLASTIC AT DISTAL TIP IS OPENING. BLOOD OR RUST INSIDE. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 21779128 ↗
• MalfunctionApr 3, 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 21768680 ↗
• MalfunctionApr 2, 2025Break; Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 21757536 ↗
• MalfunctionMar 14, 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 21610775 ↗
• MalfunctionDec 21, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18378869 ↗
• MalfunctionMay 6, 2023Break; Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THAT THE MICO BIPOLAR FORCEPS INSTRUMENT WAS FOUND TO BE BROKEN FROM TOP. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883430 ↗
• MalfunctionNov 17, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE MICRO BIPOLAR FORCEPS (MBF) HAD A DISCONNECTED WIRE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE DAMAGED CONDUCTOR WIRE WAS FOUND AFTER PROCESSING. THERE WAS NO ARCING DURING THE LAST PROCEDURE. THERE WAS NO PATIENT¿S INJURY. THE LAST PROCEDURE WAS COMPLETED ROBOTICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815730 ↗
• MalfunctionMar 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BEATING HEART REVASCULARIZATION (SINGLE VESSEL) SURGICAL PROCEDURE , THE MICRO BIPOLAR FORCEPS INSTRUMENT WAS UNABLE TO BE REMOVED FROM THE PATIENT SIDE CART (PSC). 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 MICRO BIPOLAR FORCEPS INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO VISIBLE DAMAGE WAS FOUND. THE CUSTOMER CONFIRMED THAT THE MISSING MATERIAL/DAMAGE DESCRIBED IN FAILURE ANALYSIS (FA) INVESTIGATION OCCURRED OUTSIDE OF A SURGICAL PROCEDURE. THERE WERE NO REPORT OF FRAGMENTS FALLING. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE INSTRUMENT WAS ABLE TO BE REMOVED BY BEING PRIED OFF. THE PROCEDURE WAS ALMOST COMPLETED, AND THE SURGEON UTILIZED OTHER INSTRUMENTS TO COMPLETE THE PROCEDURE. THE SITE¿S INSTRUMENT CLEANING OR STERILIZATION METHODS HAS NOT CHANGED RECENTLY. THE CUSTOMER IS UNSURE IF THERE ARE ANY IMAGES AVAILABLE OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13648798 ↗
• MalfunctionFeb 28, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, INSPECTION IDENTIFIED DAMAGE ON THE MICRO BIPOLAR FORCEPS INSTRUMENT'S CONDUCTOR WIRE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE STERILE REPROCESSOR FURTHER CLARIFIED AND CONFIRMED A COMPROMISED CONDUCTOR WIRE INSULATION AND A WIRE WAS EXPOSED. NO KNOWN ABNORMALITY OR FUNCTIONAL ISSUE WAS OBSERVED DURING THE LAST KNOWN USAGE FOR A PROCEDURE ON (B)(6) 2021 USING SYSTEM (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11390954 ↗