BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3011965 · Received March 20, 2013

    Report

    Report Number
    2955842-2013-00918
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    November 30, 2012
    Report Date
    February 21, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT ENGINEERING EVALUATION FOUND THAT THE NONCONFORMANCE WAS A DERAILED GRIP CABLE. THE GRIPS CANNOT OPEN AND CLOSE PROPERLY. THE MOVEMENT WAS HINDERED. ENGINEERING ALSO FOUND THE DERAILED GRIP CABLE WAS FRAYED. THE FRAYED CABLE SECTIONS ARE IN VARIOUS LENGTHS STICKING OUT AT THE WRIST. THE IDLER PULLEY RIM EXHIBITED DAMAGE. THE 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 DURING A DA VINCI SI TOTAL BENIGN HYSTERECTOMY PROCEDURE THE MEGASUTURECUT NEEDLE DRIVER INSTRUMENT WIRE CAME OUT OF THE PULLEY AND MALFUNCTIONED. 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
    115969 MEGASUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10120419 015

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR DA VINCI SI SYSTEM, INSTRUMENTS AND ACCESSORIES