BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21556163 · Received March 9, 2025

    Report

    Report Number
    2955842-2025-05761
    Event Type
    Malfunction
    Date Received
    March 9, 2025
    Date of Event
    January 14, 2025
    Report Date
    February 10, 2025
    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
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE BIPOLAR INSTRUMENT WAS ANALYZED BUT NOT REPLICATE THE CUSTOMER REPORTED COMPLAINT "GRASPING FORCEPS ARE NO LONGER RECOGNIZED BY THE ROBOT, ALTHOUGH THEY HAVE REMAINING LIVES". THE INSTRUMENT WAS INSTALLED ON IN-HOSE SYSTEM AND PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE LOG REVIEW SHOW 1 (ONE) RFID ERROR. ADDITIONAL OBSERVATION NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE A BROKEN CONDUCTOR WIRE WITHIN THE BIPOLAR YAW PULLEY, BETWEEN THE WIRE CRIMP ON THE GRIP AND THE SILICONE POTTING, WHICH SEALS THE WIRE ENTRANCE TO THE YAW PULLEY. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST, CONFIRMING A COMPLETE BREAK IN THE WIRE. THERMAL DAMAGE WAS FOUND ON THE YAW PULLEY NEAR THE GRIP BASE. COMPONENTS ADJACENT TO THE BROKEN WIRE DO NOT SHOW DAMAGE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO BROKEN CONDUCTOR WIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 8MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT WERE LONGER RECOGNIZED BY THE ROBOT ALTHOUGH IT HAD REMAINING LIVES. NO FURTHER INFORMATION WAS PROVIDED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO PATIENT INFORMATION WAS DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232443 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K13240201 0241 00886874119808

    Patients

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