BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16971607 · Received May 22, 2023

    Report

    Report Number
    2955842-2023-14189
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    October 2, 2020
    Report Date
    October 16, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112281
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION DID NOT CONFIRM/REPLICATE THE REPORTED COMPLAINT. NO MISALIGNMENT OF GRIPS OR CONDUCTOR WIRE DAMAGE WAS OBSERVED. THE ELECTRICAL CONTINUITY TEST PASSED. THE INSTRUMENT WAS PLACED ON SYSTEM AND PASSED THE RECOGNITION AND ENGAGEMENT TEST. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY AND THE GRIP FUNCTION WAS SUCCESSFUL. BIPOLAR ENERGY CORD WAS SUCCESSFULLY CONNECTED TO GENERATOR AND THE INSTRUMENT. ENERGY ACTIVATION TEST WAS CONDUCTED. A WET PAPER TOWEL WAS HELD BETWEEN GRIPS AND IT BEGAN TO SMOKE WHEN ENERGY PEDAL WAS PRESSED. STEAM GENERATION FROM THE TOWEL INDICATED ACTIVE POWER AND A COMPLETE CIRCUIT. NO LOSS OF POWER AND NO INTERMITTENT ENERGY WERE OBSERVED. HOWEVER, THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE BIPOLAR YAW PULLEY. BLACK CHAR MARKS WERE PRESENT AT THE GRIP BASE. ANY MATERIAL MISSING FROM THE DAMAGE OF THE YAW PULLEY IS LIKELY THERMALLY INDUCED RATHER THAN MECHANICALLY INDUCED.

    Description of Event or Problem · 0

    THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT WAS RETURNED BACK TO INTUITIVE SURGICAL, INC. (ISI) WITH NO COMPLAINT DESCRIPTION. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION, BUT NO NEW INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569991 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 470172-16 N10190729 0059 00886874112281

    Patients

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