BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA NEEDLE DRIVER INSTRUMENT

    MDR report key: 3884992 · Received June 19, 2014

    Report

    Report Number
    2955842-2014-03790
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 23, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE INSTRUMENT WAS CHECKED FOR RECOGNITION ON AN IN-HOUSE SYSTEM AND THE SYSTEM FAILED TO RECOGNIZE THE INSTRUMENT ON MULTIPLE INSTALLATION ATTEMPTS. THE POGO PINS WERE NOT STUCK OR CONTAMINATED. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THAT THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS EXHIBITING LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .131 - .199 IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE TUBE ABRASIONS WITH MATERIAL REMOVED, FOUND DURING FAILURE ANALYSIS INVESTIGATION, COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTIONS WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI GASTRIC SLEEVE PROCEDURE, THE MEGA NEEDLE DRIVER INSTRUMENT WAS NOT RECOGNIZED. THERE WAS NO REPORT OF FRAGMENTS FALLING 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
    361646 MEGA NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420194-08 M20120322 246

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR