BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASUTURECUT NEEDLE DRIVERINSTRUMENT

    MDR report key: 2981252 · Received February 27, 2013

    Report

    Report Number
    2955842-2013-00656
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING EVALUATION RESULTS CONFIRMED THE ALLEGED COMPLAINT THAT THE INSTRUMENT HAD A BROKEN WIRE. ONE GRIP CLOSE CABLE WAS FOUND TO BE BROKEN AT THE DISTAL IDLERS PULLEY. THE IDLER PULLEY WAS OBSERVED TO SPIN FREELY. THE CABLE SEGMENT WAS STICKING OUT AT THE INSTRUMENT'S WRIST. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. ENGINEERING EVALUATION ALSO FOUND DAMAGE ON THE EDGE AND ON THE SURFACE OF THE IDLER PULLEY. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER THE REPORTED BROKEN CABLE ISSUE 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 SI TOTAL BENIGN HYSTERECTOMY PROCEDURE, THE SURGICAL STAFF ALLEGEDLY NOTICED THAT THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT HAD BROKEN WIRES. THERE WERE NO MISSING OR FALLEN PIECES 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
    83801 MEGASUTURECUT NEEDLE DRIVERINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10120822 939

    Patients

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