BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE NEEDLE DRIVER INSTRUMENT

    MDR report key: 2900505 · Received January 7, 2013

    Report

    Report Number
    2955842-2013-00084
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    September 10, 2012
    Report Date
    December 11, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE CUSTOMER REPORTED FAILURE MODE WITH THE FOLLOWING CLARIFICATION. THE INSTRUMENT WAS RETURNED WITH A BROKEN GRIP CABLE. THE IDLER PULLEY SPINS FREELY AND EXHIBITS DAMAGE TO THE FACE. THE CABLE SEGMENT STICKS OUT AT THE WRIST. 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 PROSTATECTOMY PROCEDURE, THE INNER THREAD OF THE LARGE NEEDLE DRIVE INSTRUMENT BROKE. THERE WERE NO MISSING OR FALLEN PIECES 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
    7680 LARGE NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420006-06 M10110802 151

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR DA VINCI SI SURGICAL SYSTEM AND ACCESSORIES.