BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24074188 · Received January 14, 2026

    Report

    Report Number
    2955842-2026-01383
    Event Type
    Malfunction
    Date Received
    January 14, 2026
    Date of Event
    November 26, 2025
    Report Date
    February 3, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED, AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE IMAGE SHOWS DAMAGE TO THE CONDUCTOR WIRE INSULATION. THERE MAY BE MISSING PIECES OF THE INSULATION; HOWEVER, IT WAS NOT CLEAR IN THE IMAGE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE ADDITIONAL INFORMATION (IMAGE REVIEW): INSULATION OVER CONDUCTOR WIRE WAS EXPOSED, UNSURE IF THE INSTRUMENT WAS SAFE TO USE ON FUTURE CASES. THE CABLE WAS INTACT. THERE WAS NO LOSS OF CAUTERY OBSERVED. THE PROCEDURE WAS COMPLETED WITH THE SAME INSTRUMENT. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: CUSTOMER REPORTED THAT THE DAMAGE WAS FIRST OBSERVED IN STERILIZATION, WHERE THE INSULATION OVER THE BLACK CONDUCTOR WIRE APPEARED EXPOSED, LEADING STAFF TO BE UNSURE IF THE INSTRUMENT WAS SAFE FOR FUTURE USE, ALTHOUGH THE CABLE ITSELF REMAINED INTACT (NOT BROKEN IN HALF). THERE WAS NO LOSS OF CAUTERY NOTED, AND NO FRAGMENT FELL INTO THE PATIENT¿S ANATOMY. ISI DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE DAMAGED CONDUCTOR WIRE INSULATION AT THE GRIP HUB. THERE WAS NO FRAGMENTATION OF THE INSULATION, AND THE INTERNAL CONDUCTOR WIRES WERE NOT EXPOSED. ALTHOUGH THE CONDUCTOR WIRE INSULATION WAS DAMAGED, THE INTERNAL WIRE WAS NOT FRAYED OR FULLY BROKEN. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. FURTHER INSPECTION FOUND NO ABNORMALLY SHARP OR DAMAGED COMPONENTS THAT COULD HAVE CONTRIBUTED TO THE CABLE BREAKING. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF DAMAGED CONDUCTOR WIRE INSULATION IS ATTRIBUTED TO DAMAGE FROM MECHANICAL IMPACT. ACCIDENTAL DROPS OF THE INSTRUMENT OR INADVERTENT COLLISIONS WITH OTHER INSTRUMENTS OR HARD SURFACES DURING HANDLING OR USAGE CAN DAMAGE THE INSULATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FENESTRATED BIPOLAR FORCEPS HAD A COMPROMISED INSULATION CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136180 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-19 K15250702 0391 00886874119808

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES