BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE SUTURECUT NEEDLE DRIVERINSTRUMENT

    MDR report key: 3031666 · Received April 2, 2013

    Report

    Report Number
    2955842-2013-01083
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 5, 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
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT ENGINEERING EVALUATION FOUND THAT THE INSTRUMENT GRIP CLOSE CABLE WAS FOUND FRAYED AND DERAILED AT THE DISTAL IDLER PULLEY. THE GRIPS CAN STILL BE OPENED AND CLOSED, BUT MOVEMENT MAY NOT BE PRECISE. PHYSICAL DAMAGES WERE FOUND ON DISTAL IDLER PULLEY. 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

    IT WAS REPORTED THAT DURING REPROCESSING THE DA VINCI SI SURGICAL LARGE SUTURECUT NEEDLE DRIVER INSTRUMENT WAS NOTED TO HAVE A SEPARATED CABLE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134051 LARGE SUTURECUT NEEDLE DRIVERINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420296-02 M10120323 421

    Patients

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