BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 3861921 · Received February 14, 2014

    Report

    Report Number
    3006451981-2014-00131
    Event Type
    Injury
    Date Received
    February 14, 2014
    Date of Event
    May 19, 2010
    Report Date
    May 19, 2010
    Manufacturer
    COVIDIEN LLC
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL EXAMINATION OF THE INSTRUMENT REVEALED NO DAMAGE. THE JAWS WERE NOT STUCK SHUT. WHEN THE SAMPLE WAS LATCHED CLOSED THE JAWS ALIGNED PROPERLY TO EACH OTHER. THE SAMPLE OPENED AND CLOSED NORMALLY WITH MINIMAL FORCE. THE RATCHET WAS NOT STUCK AND OPENED AND LOCKED NORMALLY. COVIDIEN LP PROVIDES AN ONLINE BULLETIN TO INFORM CUSTOMERS HOW TO AVOID TISSUE BUILDUP THAT CAN LEAD TO STICKING. THIS BULLETIN REITERATES INFORMATION PROVIDED IN THE IFU WHICH 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 JAW AND LEAD TO IMPROPER PERFORMANCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE SEALING THE UTERINE ARTERY DURING A HYSTERECTOMY, THE DEVICE WOULD NO LONGER OPEN. THE PROCEDURE WAS CONVERTED TO OPEN AND THE SURGEON OPENED THE JAWS WITH HIS FINGERS. THE PATIENT WAS SAID TO BE DOING FINE POST-SURGICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98042 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC S9M0038

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention