BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24612215 · Received March 16, 2026

    Report

    Report Number
    2955842-2026-16387
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    January 19, 2026
    Report Date
    March 16, 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
    JA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE BIPOLAR INSTRUMENT HAS BEEN RETURNED AND EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED MOLDED INSULATOR ON THE JAW. THE GRIP TIP FOR THE GRIP WITH THE DISLODGED MOLDED INSULATOR DOES NOT APPEAR TO BE BENT. COMPONENTS ADJACENT TO THE DISLODGED MOLDED INSULATOR DO NOT SHOW DAMAGE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF THE DISLODGED MOLDED INSULATOR IS ATTRIBUTED TO DAMAGE DURING USE, WHICH MAY RESULT FROM AN ACCIDENTAL DROP OF THE INSTRUMENT OR INADVERTENT COLLISIONS WITH OTHER INSTRUMENTS OR HARD SURFACES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FORCE BIPOLAR INSTRUMENT HAD TIP DAMAGE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MISSING MATERIAL/DAMAGE DESCRIBED ABOVE OCCURRED DURING CENTRAL PROCESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515733 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K10250515 0166 00886874120767

    Patients

    Seq Age Sex Outcome Treatment
    1