BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE SUTURE CUT NEEDLE DRIVERINSTRUMENT

    MDR report key: 3030806 · Received April 2, 2013

    Report

    Report Number
    2955842-2013-01075
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 5, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THAT THE GRIP CABLE WAS BROKEN AND WAS STICKING OUT AT THE INSTRUMENT'S WRIST. THE IDLER PULLEY SPUN FREELY AND EXHIBITED PULLEY RIM DAMAGE. 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 SI NEPHRECTOMY PROCEDURE, THE WIRES FROM THE LARGE SUTURECUT NEEDLE DRIVER INSTRUMENT BECAME UNRAVELLED. NO MISSING OR FALLEN PIECES WERE REPORTED TO HAVE FALLEN INTO THE 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
    134176 LARGE SUTURE CUT NEEDLE DRIVERINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420296-02 M10121123 713

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES