BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37 CM

    MDR report key: 3772353 · Received February 18, 2014

    Report

    Report Number
    3006451981-2014-00309
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    August 4, 2011
    Report Date
    August 9, 2011
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE JAWS OF THE INCIDENT SAMPLE DID NOT HAVE TISSUE BETWEEN THEM AND WERE NOT STUCK SHUT. WHEN THE HANDLE WAS ACTIVATED, THE JAWS OPENED AND CLOSED NORMALLY. THE KNIFE EXTENDED AND RETRACTED NORMALLY WHEN THE TRIGGER WAS ACTIVATED. THE KNIFE EDGE WAS NOT DAMAGED. 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 DURING THE PROCEDURE, THE DEVICE WOULD NO LONGER OPEN. TISSUE AROUND THE JAWS WAS RESECTED AND THE DEVICE WAS REMOVED. ANOTHER DEVICE WAS SUED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THERE WAS NO BLEEDING AND NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103614 LIGASURE ATLAS HANDSWITCHING 37 CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S1C0011X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK