BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37 CM

    MDR report key: 3772351 · Received February 18, 2014

    Report

    Report Number
    3006451981-2014-00313
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    August 8, 2011
    Report Date
    August 15, 2011
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL INSPECTION OF THE INCIDENT DEVICE REVEALED TISSUE IN-BETWEEN THE JAWS. THE IFU FOR THIS DEVICE STATES THAT IF THE JAWS ARE NOT CLEANED AS INSTRUCTED, ESCHAR CAN BUILD UP AND CAUSE THE JAWS TO STICK TO THE SEALED TISSUE. THIS CAN LEAD TO DIFFICULTY IN OPENING AND CLOSING THE DEVICE. KEEP THE JAWS OF THE INSTRUMENT CLEAN AT ALL TIMES AND CLEAN THE INSTRUMENT MORE OFTEN WHEN WORKING IN A BLOODY FIELD. IF CONSISTENT STICKING IS ENCOUNTERED, REDUCE THE BAR SETTING. DO NOT RE-USE OR REPROCESS THE DEVICE AS THIS CAN DAMAGE THE SURFACE OF THE JAWS AND LEAD TO IMPROPER PERFORMANCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER THE SEAL WAS COMPLETED SUCCESSFULLY, THE TISSUE STUCK TO THE DEVICE AND THE REMOVAL OF THE DEVICE CAUSED OOZING OF UNDER 250CC. THE DEVICE WAS SUED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103014 LIGASURE ATLAS HANDSWITCHING 37 CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S1B0006X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK