BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3191077 · Received June 26, 2013

    Report

    Report Number
    2955842-2013-02302
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 30, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THERE WAS A BROKEN GRIP CLOSE CABLE NEAR THE PROXIMAL PULLEYS AND PROXIMAL CLEVIS CABLE HOLE. THE CABLE SEGMENT WAS STICKING OUT AT THE INSTRUMENT'S WRIST. THE IDLER PULLEY SPUN FREELY AND DID NOT EXHIBIT ANY DAMAGE. AN ADDITIONAL OBSERVATION NOT REPORTED BY THE CUSTOMER WAS A WEARING PROXIMAL CLEVIS. THE PROXIMAL CLEVIS CABLE HOLD EXHIBITED WEAR ON ONE EDGE. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. EVIDENCE NOT CONCLUSIVE, BUT THE WEAR ON THE HOLE MAY HAVE CONTRIBUTED TO THE CABLE BREAKAGE. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S HYSTERECTOMY PROCEDURE, THE CABLE ON THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT BROKE. NOTHING REPORTEDLY FELL INTO A PATIENT. 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
    289573 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10121106 767

    Patients

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