BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3011961 · Received March 20, 2013

    Report

    Report Number
    2955842-2013-00909
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 20, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT ENGINEERING EVALUATION FOUND THAT THE INSTRUMENT LINES WERE FRAYED. THE PITCH CABLE WAS BROKEN AT THE DISTAL END. THE CABLE SEGMENT THAT CONTAINED THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. THE OTHER CABLES AT THE WRIST WERE NOT DAMAGED. ENGINEERING ALSO FOUND THE BACK IDLER PULLEY WAS CORRODED. A FEW BACK IDLER PULLEYS EXHIBITED SOME RUST. THE IDLER PULLEYS WERE NOT SEIZED AND STILL ROTATED FREELY. ENGINEERING CONCLUDED THE DAMAGE WAS LIKELY DUE TO IMPROPER CLEANING. NO OTHER DAMAGE WAS FOUND. THE CLEANING AND STERILIZATION USER MANUAL SPECIFICALLY STATES: O WHEN SCRUBBING THE TIP OF CAUTERY INSTRUMENTS, TAKE CARE NOT TO DAMAGE THE INSULATION. O DO NOT EXPOSE INSTRUMENTS TO HYDROGEN PEROXIDE (H2O2), BLEACH, OR ALKALINE-BASED CLEANING AGENTS, AS THIS MAY RESULT IN INSTRUMENT DAMAGE. O PROLONGED EXPOSURE TO EITHER ULTRASONIC CLEANING OR CLEANING AGENTS MAY RESULT IN INSTRUMENT DAMAGE. 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 SI SIGMOID COLECTOMY PROCEDURE THE MEGA SUTURE CUT NEEDLE DRIVER INSTRUMENT LINES WERE NOTED TO BE FRAYED. 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
    116479 MEGASUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10121011 347

    Patients

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