BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 2781614 · Received October 10, 2012

    Report

    Report Number
    2955842-2012-00519
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 12, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT ONE GRIP CLOSE CABLE WAS FOUND TO BE BROKEN NEAR THE PROXIMAL PULLEYS AND PROXIMAL CLEVIS CABLE HOLE. THE IDLER PULLEY SPINS FREELY AND DID NOT EXHIBIT ANY DAMAGE. THE CABLE SEGMENT STICKS OUT AT WRIST. PROXIMAL CLEVIS CABLE HOLE EXHIBITED WEAR ON ONE EDGE. NO OTHER DAMAGE WAS FOUND. 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 VAGINAL CUFF CLOSURE IN THE COURSE OF A DAVINCI S HYSTERECTOMY PROCEDURE, THE SURGEON NOTICED THAT THE MEGA SUTURE CUT NEEDLE DRIVER INSTRUMENT DID NOT HAVE ANY GRIP STRENGTH; UPON FURTHER INSPECTION THE TEAM NOTICED THAT ONE OF THE INTERNAL CABLES WAS BROKEN. THE INSTRUMENT WAS EXCHANGED AND THE SURGICAL PROCEDURE WAS COMPLETED AS INTENDED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10110803 057

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI S SURG SYSTEM, INSTRUMENTS & ACCESSORIES