BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3002767 · Received March 13, 2013

    Report

    Report Number
    2955842-2013-00813
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 11, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THAT THE INSTRUMENT WAS RETURNED WITH ONE GRIP CLOSE CABLE BROKEN NEAR THE PROXIMAL PULLEYS AND PROXIMAL CLEVIS CABLE HOLE. THE IDLER PULLEY SPUN FREELY AND DID NOT EXHIBIT DAMAGE. THE CABLE SEGMENT STUCK OUT AT THE WRIST. ENGINEERING EVALUATION ALSO FOUND, THAT THE PROXIMAL CLEVIS CABLE HOLE EXHIBITED WEAR ON ONE EDGE. THE OTHER CABLES AT THE WRIST WERE NOT DAMAGED. ENGINEERING CONCLUDED THAT WEAR ON THE HOLE WAS LIKELY DUE TO THE CABLE BREAKAGE. NO OTHER DAMAGE WAS 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 DURING A DA VINCI S HYSTERECTOMY PROCEDURE, THE WIRE ON THE MEGASUTURECUT NEEDLE DRIVER INSTRUMENT SEPARATED. NO MISSING OR FALLEN PIECES WERE REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105621 MEGASUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10120822 917

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SURG SYS., INSTRUMENTS AND ACCESSORIE