BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE DRIVER INSTRUMENT

    MDR report key: 3770808 · Received April 24, 2014

    Report

    Report Number
    2955842-2014-02537
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 31, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT THE INSTRUMENT HOUSING HAD TWO OUT OF FOUR SNAPS BROKEN, AND THREE OUT OF FOUR HOUSING PINS WERE BROKEN. THE CHASSIS WAS UNDAMAGED. IT WAS CONCLUDED THAT THE DAMAGE WAS LIKELY DUE TO MISHANDLING/MISUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REPROCESSING OF A DA VINCI NEEDLE DRIVER INSTRUMENT, THE BLUE HOUSING WAS IDENTIFIED AS BEING LOOSE. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT, AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249019 NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420117-04 S10110429 366

    Patients

    Seq Age Sex Outcome Treatment
    1