BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24426214 · Received February 24, 2026

    Report

    Report Number
    2955842-2026-06506
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    January 7, 2026
    Report Date
    February 24, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE BIPOLAR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A DISLODGED MOLDED INSULATOR ON THE JAW. THE GRIP TIP FOR THE GRIP WITH THE DISLODGED MOLDED INSULATOR DOES APPEAR TO BE BENT. COMPONENTS ADJACENT TO THE DISLODGED MOLDED INSULATOR SHOW DAMAGE WHICH MAY INDICATE POTENTIAL MISHANDLING OR MISUSE OF THE INSTRUMENT. THE COMPLAINT REGARDING GRIP DOES NOT LINE UP WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF A DISLODGED MOLDED INSULATOR CAN RESULT FROM MECHANICAL IMPACT OR EXCESSIVE FORCE APPLIED TO THE JAWS, SUCH AS AN ACCIDENTAL DROP OF THE INSTRUMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT GRIP DID NOT LINE UP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157179 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K11250515 0301 00886874120767

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DA VINCI INSTRUMENTS AND ACCESSORIES