BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA NEEDLE DRIVER INSTRUMENT

    MDR report key: 3253358 · Received July 29, 2013

    Report

    Report Number
    2955842-2013-02816
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 10, 2013
    Report Date
    July 9, 2013
    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. ENGINEERING WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE CUSTOMER REPORTED COMPLAINT THAT THE INSTRUMENT WAS NOT RECOGNIZED COULD NOT BE REPLICATED. THE INSTRUMENT WAS CHECKED FOR RECOGNITION ON AN IN-HOUSE IS3000 SYSTEM AND THE SYSTEM SUCCESSFULLY RECOGNIZED THE INSTRUMENT. THE POGO PINS WERE NOT STUCK OR CONTAMINATED. THE DCP (DALLAS CHIP PROGRAMMER) VERIFICATION OF THE INSTRUMENT PASSED. ADDITIONAL DAMAGE ENGINEERING FOUND THAT WAS NOT REPORTED BY THE SITE WAS THE INSTRUMENT GRIP CABLES WERE BROKEN. THE ONE GRIP CLOSE CABLE WAS BROKEN AT THE DISTAL IDLERS. THE IDLER PULLEY SPUN FREELY AND DID NOT EXHIBIT DAMAGE. THE CABLE SEGMENT STUCK OUT AT THE WRIST. THE CABLE BROKE UNDER TENSILE LOADING. THE OTHER CABLES AT THE WRIST WERE UNDAMAGED. NO OTHER DAMAGE WAS FOUND. 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 PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE THE MEGA NEEDLE DRIVER INSTRUMENT WAS NOT RECOGNIZED BY THE SYSTEM. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354043 MEGA NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420194-08 M10126820 660

    Patients

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