BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA NEEDLE DRIVER INSTRUMENT

    MDR report key: 2930213 · Received January 25, 2013

    Report

    Report Number
    2955842-2013-00287
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. NO REASON FOR RETURN WAS PROVIDED. A COMPLAINT CANNOT BE CONFIRMED OR DENIED. ADDITIONAL OBSERVATION NOT REPORTED BY SITE IS A BROKEN CABLE. ONE GRIP CLOSE CABLE IS BROKEN NEAR THE PROXIMAL PULLEYS AND PROX CLEVIS CABLE HOLE. IDLER PULLEY SPINS FREELY AND DOES NOT EXHIBIT DAMAGE. CABLE SEGMENT STICKS OUT AT WRIST. PROX CLEVIS CABLE HOLE EXHIBITS WEAR ON ONE EDGE. OTHER CABLES AT WRIST ARE NOT DAMAGED. NO OTHER DAMAGE 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

    ON (B)(4) 2012, THE MEGA NEEDLE DRIVER INSTRUMENT WAS RETURNED WITHOUT A COMPLAINT FILED AGAINST IT. THE FAILURE ANALYSIS TEAM DETERMINED THE INSTRUMENT HAD A BROKEN CABLE. NO INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36052 MEGA NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420194-08 M10120420 131

    Patients

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