BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22591709 · Received July 24, 2025

    Report

    Report Number
    2955842-2025-31025
    Event Type
    Malfunction
    Date Received
    July 24, 2025
    Date of Event
    June 17, 2025
    Report Date
    July 3, 2025
    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
    AU
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE 8MM FORCE BIPOLAR INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED, AND THE FINDINGS DID NOT REPLICATE OR CONFIRM THE CUSTOMER REPORTED EVENT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE JAW OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS CONTACTED TO THE ERBE GENERATOR AND PASSED BIPOLAR ENERGY RECOGNITION. THE INSTRUMENT WAS CONNECTED TO AN IN-HOUSE BIPOLAR CAUTERY CABLE ON IN-HOUSE SYSTEM AND PASSED ENERGY DELIVERY TEST. THE INSTRUMENT WAS FULLY FUNCTIONAL. NO PRODUCT ISSUE WAS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY (WITHOUT LYMPHADENECTOMY) SURGICAL PROCEDURE, THE 8MM FORCE BIPOLAR INSTRUMENT DID NOT RESPOND PROPERLY WHEN USED. 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 DEVICE INITIALLY MOVED IN THE OPPOSITE DIRECTION BUT DID NOT REMAIN STATIONARY OR IN AN OPEN POSITION, AND NO CABLES WERE DAMAGED. THE ISSUE WAS RESOLVED BY REPLACING THE INSTRUMENT, ALLOWING THE OPERATION TO CONTINUE WITHOUT FURTHER PROBLEMS. THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2126710 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K11250130 0204 00886874120767

    Patients

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