BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 1982694 · Received February 2, 2011

    Report

    Report Number
    3006451981-2011-00020
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING LAP NISSAN PROCEDURE, THE LIGASURE HAND PIECE WORKED AT FIRST (MFR REPORT # 1717344-2011-00065), BUT THEN STOPPED SEALING COMPLETELY EVEN THOUGH AN END TONE, INDICATING A COMPLETED SEAL CYCLE, WAS HEARD. BLEEDING OCCURRED WHEN THEY CUT AFTER THEY HEARD THE END TONE. AFTER SEVERAL TRIES AND THE SAME THING HAPPENING, THEY SWITCHED TO A SECOND LS1037 (MFR REPORT # 1717344-2011-00065) AND USED IT. THE SAME THING OCCURRED. THEY, THEN SWITCHED TO A SECOND FORCETRIAD AND CONNECTED THE SECOND (B)(4) (MFR REPORT # 1717344-2011-00065) TO IT. THEY AGAIN HAD THE SAME TROUBLE SEALING, GETTING AN END TONE, BUT NO SEAL. BECAUSE OF THE BLEEDING, THEY CONVERTED TO AN OPEN PROCEDURE AND COMPLETED. THE PT IS OK AND NO TRANSFUSION WAS NECESSARY. THE SITE WAS UNABLE TO MAINTAIN IDENTITY OF THE FIRST VERSUS THE 2ND (B)(4) AND FORCETRIADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S9M0021

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other FORCETRIAD- ENERGY PLATFORM- S/N (B)(4)| FORCETRIAD- ENERGY PLATFORM- S/N (B)(4)