BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 25196204 · Received May 17, 2026

    Report

    Report Number
    2955842-2026-25215
    Event Type
    Malfunction
    Date Received
    May 17, 2026
    Date of Event
    February 6, 2026
    Report Date
    May 15, 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
    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 NOT APPEAR TO BE BENT. COMPONENTS ADJACENT TO THE DISLODGED MOLDED INSULATOR DO NOT SHOW DAMAGE. THE COMPLAINT REGARDING BLADE DAMAGE WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF DISLODGED MOLDED INSULATOR IS ATTRIBUTED TO DAMAGE DURING USE WHICH 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 BLADE WAS BROKEN. A SPARE INSTRUMENT WAS USED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: FORCE BIPOLAR WAS FOUND TO HAVE BROKEN GRIP. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO NOTED DAMAGE. GRIP WAS FOUND TO BE DAMAGED. NO PART DETACHED FROM THE INSTRUMENT. IT WAS STILL LOOSELY ATTACHED TO THE INSTRUMENT. NO REPORT OF ANY FRAGMENT FALLING INTO THE PATIENT. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163294 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K10240415 0035 00886874120767

    Patients

    Seq Age Sex Outcome Treatment
    1