BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 2930212 · Received January 25, 2013

    Report

    Report Number
    2955842-2013-00286
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 24, 2012
    Report Date
    December 26, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE CUSTOMER INITIALLY REPORTED A FRAYED WIRE, HOWEVER, FOR CLARIFICATION THE DAMAGED INSTRUMENT COMPONENT WAS A BROKEN GRIP CABLE. BASED ON THIS CLARIFICATION, THE CUSTOMER REPORTED COMPLAINT IS CONFIRMED. ONE GRIP CLOSE CABLE IS BROKEN AT THE DISTAL IDLERS. IDLER PULLEY SPINS FREELY AND WAS NOT DAMAGED. CABLE SEGMENT STICKS OUT AT WRIST. OTHER CABLES AT WRIST ARE NOT DAMAGED. 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 OBSERVED DURING CENTRAL PROCESSING THAT THE MEGA SUTURE CUT NEEDLE DRIVER INSTRUMENT HAD A FRAYED WIRE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35208 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10120920 044

    Patients

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