BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA NEEDLE DRIVER INSTRUMENT

    MDR report key: 3964855 · Received July 29, 2014

    Report

    Report Number
    2955842-2014-04596
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE CUSTOMER REPORTED COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE INSTRUMENT GRIP CABLE WAS FRAYED AT THE DISTAL IDLER PULLEY. THE FRAYED STRANDS STUCK OUT AT THE WRIST. OTHER CABLES AT WRIST WERE NOT DAMAGED. FAILURE ANALYSIS ALSO FOUND THE FOLLOWING: ONE GRIP CLOSE CABLE WAS DERAILED AT THE DISTAL IDLER PULLEY. THE GRIPS CAN STILL OPEN AND CLOSE, BUT MOVEMENT MAY NOT BE PRECISE. CABLE DERAILMENT WAS LIKELY DUE TO CABLE LOSING CONTACT WITH PULLEY DURING WRIST ARTICULATION. THE FLEET ANGLE BETWEEN PROXIMAL AND DISTAL PULLEYS MAY CONTRIBUTE TO DERAILMENT. THE INSTRUMENT DISTAL PULLEY HAD MECHANICAL INDENTATIONS/BURRS. THERE WERE INDENTATIONS AT THE EDGE OF THE DISTAL PULLEY AND VISIBLE SCRATCHES ON THE SURFACE OF THE PULLEY. FAILURE ANALYSIS CONCLUDED THAT MECHANICAL INDENTATIONS/BURRS DAMAGE MAY BE DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS -HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER FRAYED GRIP CABLE WERE TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A DA VINCI INGUINAL HERNIA REPAIR PROCEDURE WHERE THE CABLE HAD SNAPPED ON THE MEGA NEEDLE DRIVER INSTRUMENT. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441902 MEGA NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420194-08 M10130115 680

    Patients

    Seq Age Sex Outcome Treatment
    1