BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT

    MDR report key: 3092029 · Received May 3, 2013

    Report

    Report Number
    2955842-2013-01512
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 25, 2013
    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. ENGINEERING CONFIRMED THE ALLEGED COMPLAINT: THE GRIP CABLE WAS FRAYED AT THE DISTAL IDLER PULLEY AND WAS STICKING OUT AT THE INSTRUMENT'S WRIST. ADDITIONAL OBSERVATIONS WERE FOUND THAT WERE NOT INITIALLY REPORTED BY THE CUSTOMER. ONE GRIP CLOSE CABLE WAS DERAILED AT THE DISTAL IDLER PULLEY. THE GRIPS CAN STILL OPEN AND CLOSE BUT MOVEMENT MAY NOT BE PRECISE. THE CABLE DERAILMENT WAS LIKELY DUE TO CABLE LOSING CONTACT WITH THE PULLEY DURING WRIST ARTICULATION. THE FLEET ANGLE BETWEEN THE PROXIMAL AND DISTAL PULLEYS MAY HAVE CONTRIBUTED TO THE CABLE DERAILMENT. THE SCRATCHES ON THE DISTAL PULLEY LOOKED LIKE THEY CAME FROM THE CABLE. ENGINEERING EVALUATION ALSO FOUND THAT THE DISTAL END OF THE INSTRUMENT'S MAIN TUBE EXHIBITED VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL AND HAD A ROUGH SURFACE FINISH. THE SCRATCHES WERE SHORT IN LENGTH AND WERE NOT AXIALLY ALIGNED WITH THE TUBE. ENGINEERING CONCLUDED THAT THE DAMAGE MAY BE DUE TO MISHANDLING. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) 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 REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    DURING A DA VINCI SI SACROCOLPOPEXY PROCEDURE, THE WIRES ON THE MEGA SUTURECUT NEEDLE DRIVER REPORTEDLY BROKE. NOTHING REPORTEDLY FELL 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
    194170 MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10120427 683

    Patients

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