BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA NEEDLE DRIVER INSTRUMENT

    MDR report key: 3842344 · Received June 1, 2014

    Report

    Report Number
    2955842-2014-03349
    Event Type
    Malfunction
    Date Received
    June 1, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 7, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. 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.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT THE GRIP CABLE WAS BROKEN AT THE DISTAL IDLERS. THE CABLE SEGMENT STUCK OUT AT THE INSTRUMENT'S WRIST. THE IDLER PULLEY SPUN FREELY AND DID NOT EXHIBIT ANY DAMAGE. THE OTHER CABLES AT THE INSTRUMENT'S WRIST WERE INTACT AND UNDAMAGED. FAILURE ANALYSIS INVESTIGATION ALSO FOUND SCRATCHES ON THE SURFACE OF THE DISTAL PULLEY. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE BROKEN CABLE, IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI HERNIA REPAIR PROCEDURE, A WIRE BROKE AT THE END OF THE MEGA NEEDLE DRIVER INSTRUMENT. THE INSTRUMENT WAS NOT USED IN THE PROCEDURE. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A 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
    320723 MEGA NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420194-10 M10140213 851

    Patients

    Seq Age Sex Outcome Treatment
    1