BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 4202955 · Received October 27, 2014

    Report

    Report Number
    1717344-2014-00939
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    May 13, 2014
    Report Date
    October 10, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED LF5544 WAS RECEIVED FOR EVALUATION AND VISUAL INSPECTION FOUND NO DEFECTS. THE CUSTOMER REPORTED THAT THE SURGEON COULD NOT PULL THE CUTTING TRIGGER SO THE SURGEON COULD NOT CUT THE TISSUE. THE REPORTED CONDITION WAS CONFIRMED. THE INVESTIGATION FOUND THE KNIFE DOES NOT EXTEND OR RETRACT WHEN THE TRIGGER IS ACTIVATED. THE KNIFE IS CONTACTING THE BACK OF THE SEAL PLATE. THIS CAN HAPPEN WHEN EXCESSIVE TENSION IS PLACED ON THE JAWS, FORCING THEM OUT OF ALIGNMENT. THE INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THE REPORTED EVENT TO BE USER ERROR. THE IFU STATES: DO NOT TURN THE ROTATION WHEEL WHEN THE HANDLE IS FULLY CLOSED AND LATCHED. PRODUCT DAMAGE MAY OCCUR. DO NOT APPLY FORCE TO THE SHAFT OF THE INSTRUMENT CAUSING TENSION OR BOWING AS THIS COULD MAKE THE KNIFE DIFFICULT TO DEPLOY AND THE TRIGGER MAY NOT RETURN TO ITS NORMAL POSITION. THE CUSTOMER ADDITIONALLY REPORTED THAT THE BOOT SILICON PART OF THE JAWS WAS TORN. THE REPORTED CONDITION WAS NOT CONFIRMED. THE CLEAR INSULATION WAS INTACT AND NOT DAMAGED. THE SAMPLE PASSED HI-POT TESTING. MANUFACTURING NON-CONFORMANCES WERE REVIEWED. NO ENTRIES PERTINENT TO THE CUSTOMER'S REPORT WERE NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CLEAR INSULATION BECAME TORN DURING THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681898 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP LF5544 245313X

    Patients

    Seq Age Sex Outcome Treatment
    1