BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 4092577 · Received September 8, 2014

    Report

    Report Number
    1717344-2014-00802
    Event Type
    Malfunction
    Date Received
    September 8, 2014
    Date of Event
    July 17, 2013
    Report Date
    September 8, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE KNIFE DID NOT ADVANCE WHEN THE TRIGGER WAS ACTIVATED AND IT WAS FOUND THAT THE KNIFE WAS HITTING THE BACK OF THE BLUE JAW SEAL PLATE. THIS CAN HAPPEN WHEN THE USER PLACES EXCESSIVE TENSION ON THE JAWS, FORCING THEM OUT OF ALIGNMENT. THE IFU CAUTIONS THE USER TO 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. WHEN THE KNIFE CONTACTED THE BACK OF THE SEAL PLATE, THE TRIGGER WAS FORCED AND THIS CAUSED THE WEBBING TO PROTRUDE. THE WEBBING WAS BOTH SHARP AND NOT SHARP. THE IFU STATES TO GENTLY PULL THE CUTTING TRIGGER TO ENGAGE THE CUTTING MECHANISM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DEVICE DID NOT CUT DURING A TOTAL HYSTERECTOMY WITH BILATERAL ADNEXECTOMY. A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE AND THERE WAS NO INJURY TO THE PT. THE DEVICE WAS RETURNED TO COVIDIEN AND VISUAL INSPECTION DISCOVERED THAT THE WEBBING WAS PROTRUDING FROM THE HINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551127 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYS GEI COVIDIEN LP 248565X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK