BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 2980721 · Received February 27, 2013

    Report

    Report Number
    2955842-2013-00644
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    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 WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE GRIP CABLE WAS FRAYED AT THE DISTAL IDLER PULLEY AND THE FRAYED STRANDS WERE STUCK OUT AT THE WRIST. THE OTHER CABLES AT WRIST WERE NOT DAMAGED. ENGINEERING EVALUATION ALSO FOUND THE GRIP CABLE WAS DERAILED. ALTHOUGH THE CABLE WAS DERAILED AT THE DISTAL IDLER PULLEY THE JAWS STILL OPENED AND CLOSED BUT THE MOVEMENT WAS NOT PRECISE. ENGINEERING CONCLUDED THAT CABLE DERAILMENT WAS LIKELY DUE TO THE CABLE LOSING CONTACT WITH PULLEY DURING WRIST ARTICULATION THUS CAUSING THE NON-INTUITIVE MOTION EXPERIENCED BY THE CUSTOMER. THE FLEET ANGLE BETWEEN PROXIMAL AND DISTAL PULLEYS MAY HAVE CONTRIBUTED TO THE DERAILMENT. IN ADDITION, ENGINEERING EVALUATION ALSO FOUND SCRATCHES ON THE SURFACE OF THE DISTAL 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 A DA VINCI SI SACROCOLPOPEXY PROCEDURE, THE WIRE ON THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS TWISTED SO THE INSTRUMENT DID NOT HAVE FULL RANGE OF MOTION. 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
    83930 MEGASUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10121115 754

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES