BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3891903 · Received June 24, 2014

    Report

    Report Number
    2955842-2014-03864
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 30, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT ONE GRIP CABLE WAS BROKEN AT THE DISTAL IDLERS. THE CABLE SEGMENT STUCK OUT AT THE INSTRUMENT'S WRIST. THE IDLER PULLEY SPUN FREELY AND DID NOT EXHIBIT ANY DAMAGE. THE OTHER CABLES AT THE INSTRUMENT'S WRIST WERE INTACT AND UNDAMAGED. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE BROKEN CABLE, IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REPROCESSING OF A DA VINCI MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT, BROKEN WIRES WERE OBSERVED AT THE BASE OF THE TIPS. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT, AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368366 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-03 M10140120 961

    Patients

    Seq Age Sex Outcome Treatment
    1