BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 20CM

    MDR report key: 3173162 · Received June 5, 2013

    Report

    Report Number
    3006451981-2013-00171
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Report Date
    May 17, 2013
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION NOTED AN EXCESSIVE AMOUNT OF DRIED BLOOD AND TISSUE IN AND AROUND THE JAWS OF THE DEVICE. AFTER THE JAWS WERE FORCED OPEN, THEY LATCHED AND UNLATCHED NORMALLY. THE JAWS WERE CLEANED AND THE DEVICE WAS ACTIVATED ON SIMULATED TISSUE WITH ACCEPTABLE RESULTS. THE JAWS DID NOT STICK TO OR LOCK ONTO THE SIMULATED TISSUE. ALTHOUGH COVIDIEN CONFIRMED THE CUSTOMER'S REPORT, THE REPORTED EVENT IS ATTRIBUTED TO THE IMPROPER OR INFREQUENT CLEANING OF THE JAWS OF THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE JAWS OF THE DEVICE CLOSED AND WOULD NOT RE-OPEN. ADDITIONAL QUESTIONS HAVE BEEN ASKED OF THE SITE. TO DATE, THE SITE HAS NOT PROVIDED ADDITIONAL INFORMATION REGARDING THE DEVICE OR THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249564 LIGASURE ATLAS HANDSWITCHING 20CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S2G0005X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK