BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3133400 · Received May 29, 2013

    Report

    Report Number
    2955842-2013-01863
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 9, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. RECEIVED THE INSTRUMENT INVOLVED WITH THE COMPLAINT. ENGINEERING CONFIRMED A BROKEN GRIP CLOSE CABLE AT THE DISTAL IDLERS. THE IDLER PULLEY SPUN FREELY AND WAS NOT DAMAGED. THE CABLE SEGMENT WAS STICKING OUT AT THE INSTRUMENT'S WRIST. OTHER CABLES AT THE INSTRUMENT'S WRIST WERE NOT DAMAGED. ADDITIONAL OBSERVATIONS THAT WERE NOT INITIALLY REPORTED BY THE CUSTOMER WERE SCRATCHES ON THE SURFACE OF THE DISTAL PULLEY. ENGINEERING WAS UNABLE TO CONCLUDE HOW THE PULLEY DAMAGE OCCURRED. 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

    DURING A DA VINCI S HYSTERECTOMY PROCEDURE, THE CABLE ON THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT REPORTEDLY 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
    237307 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10130211 720

    Patients

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