BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 2843225 · Received November 21, 2012

    Report

    Report Number
    2955842-2012-01060
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 26, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    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 IS BROKEN AT THE DISTAL IDLERS. THE IDLER PULLEY SPINS FREELY AND WAS NOT DAMAGED. THE CABLE SEGMENT STICKS OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST ARE NOT DAMAGED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE DAMAGE FOUND TO THE INSTRUMENT'S PITCH CABLE FOUND DURING FAILURE ANALYSIS COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE WIRES ON THE MEGASUTURECUT NEEDLE DRIVER INSTRUMENT FRAYED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. 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
    1 MEGASUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10120723 728

    Patients

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