BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE CURVED SHEARS INSERT

    MDR report key: 2923463 · Received January 22, 2013

    Report

    Report Number
    2955842-2013-00248
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. COMPLAINT OF BROKEN TIP CANNOT BE CONFIRMED. INSERT DOES NOT HAVE ANY BROKEN PIECES. INSERT WAS RETURNED INSTALLED ON ACE INSTRUMENT UNDER RMA 1045754. INSTRUMENT WAS INSTALLED ON IN-HOUSE IS3000 SYSTEM AND DRIVEN. CLAMP ARM OPENED/CLOSED FINE. ADDITIONAL OBSERVATION NOT REPORTED BY SITE IS A FUNCTIONAL TEST FAILURE. HARMONIC HANDPIECE AND GENERATOR WERE USED TO PERFORM A FUNCTIONAL ENERGY TEST. GENERATOR PRODUCTED AN ERROR MESSAGE DURING TEST OF HARMONIC ENERGY (BOTH MAX AND MIN FOOTSWITCH PEDALS). FUNCTIONAL TEST FAILURE SUGGESTS A DEFECT IN THE INSERT, BUT VISUAL INSPECTION SHOWS NO OBVIOUS DAMAGE TO CURVED BLADE. NO OTHER DAMAGE FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI HYSTERECTOMY PROCEDURE, DURING SET UP, THE SURGICAL STAFF REPORTED SEEING A BROKE TIP ON THE HARMONIC ACE CURVED SHEARS INSERT ACCESSORY. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29954 HARMONIC ACE CURVED SHEARS INSERT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400272-02 M10120608

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES