BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE NEEDLE DRIVER INSTRUMENT

    MDR report key: 2912363 · Received January 11, 2013

    Report

    Report Number
    2955842-2013-00162
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE CUSTOMER INITIALLY REPORTED 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. ADDITIONAL FINDING: INDENTATION AND SCRATCHES ON PULLEY. THERE ARE SCRATCHES AND INDENTATION ON BOTH DISTAL PULLEYS. 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 LARGE NEEDLE DRIVER INSTRUMENT HAD A WIRE FRAYED AT THE MIDDLE OF THE INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19118 LARGE NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420006-06 M10120918 312

    Patients

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