BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASUTURECUT NEEDLE DRIVER

    MDR report key: 2930205 · Received January 25, 2013

    Report

    Report Number
    2955842-2013-00298
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 3, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE CUSTOMER INITIALLY REPORTED BROKEN WIRE; HOWEVER, FOR CLARIFICATION THE DAMAGED INSTRUMENT COMPONENT WAS A FRAYED GRIP CABLE. BASED ON THIS CLARIFICATION, THE CUSTOMER'S REPORTED COMPLAINT IS CONFIRMED. THE GRIP CABLE WAS FRAYED AT THE DISTAL IDLER PULLEY. FRAYED STRANDS WERE OBSERVED TO BE STICKING OUT AT THE WRIST. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. ADDITIONAL FINDING: THE GRIP CABLE WAS ALSO FOUND TO BE DERAILED AT THE DISTAL IDLER PULLEY. THE CABLE DERAILMENT IS LIKELY DUE TO CABLE LOSING CONTACT WITH PULLEY DURING WRIST ARTICULATION. THE FLEET ANGLE BETWEEN PROXIMAL AND DISTAL PULLEYS MAY HAVE CONTRIBUTED TO THE DERAILMENT. 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 SURGICAL PROCEDURE, THE SURGICAL STAFF REPORTED SEEING A BROKEN CABLE. THERE WERE NO MISSING OR FALLEN PIECES 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
    35609 MEGASUTURECUT NEEDLE DRIVER ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10120704 100

    Patients

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