BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT

    MDR report key: 2964027 · Received February 15, 2013

    Report

    Report Number
    2955842-2013-00517
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING EVALUATION CONFIRMED THE ALLEGED COMPLAINT OF A WIRE STICKING OUT. ONE GRIP CLOSE CABLE WAS FOUND TO BE BROKEN AT THE DISTAL IDLERS. THE IDLER PULLEY WAS OBSERVED TO SPIN FREELY AND WAS NOT DAMAGED. A CABLE SEGMENT WAS FOUND TO BE STICKING OUT AT WRIST. OTHER CABLES AT THE INSTRUMENT'S WRIST WERE NOT DAMAGED. ENGINEERING EVALUATION ALSO FOUND SCRATCHES ON THE SURFACE OF THE DISTAL 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 ALLEGED THAT A WIRE WAS OBSERVED TO BE STICKING OUT FROM THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT . THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH A LARGE NEEDLE DRIVER INSTRUMENT AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67164 MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10120829 647

    Patients

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