BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE NEEDLE DRIVER INSTRUMENT

    MDR report key: 2944610 · Received February 5, 2013

    Report

    Report Number
    2955842-2013-00400
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 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 OPEN/CLOSE CABLE FRAYED AT THE DISTAL IDLER PULLEY. THE FRAYED STRANDS STICK OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST ARE NOT DAMAGED. ENGINEERING EVALUATION ALSO FOUND THAT THE DISTAL IDLER PULLEY ON WHICH THE BROKEN CABLE WAS SEATED HAD A SECTION THAT IS BENT INWARDS. ENGINEERING CONCLUDED THAT THE DAMAGE TO THE PULLEY IS LIKELY DUE TO MISHANDLING AND THAT THE DAMAGE LIKELY CONTRIBUTED TO THE CABLE BREAKAGE. THE DISTAL END OF THE MAIN TUBE HAS VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES ARE .090 - .220 IN LENGTH AND WERE ALIGNED WITH THE TUBE AXIS. ENGINEERING CONCLUDED THAT THE DAMAGE TO THE MAIN TUBE WAS LIKELY DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP. 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 SET-UP OF A DA VINCI SI SURGICAL PROCEDURE, IT WAS NOTED THAT THE CABLE ON THE LARGE NEEDLE DRIVER INSTRUMENT WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48432 LARGE NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420006-06 M10121120 533

    Patients

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