BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 2112334 · Received May 25, 2011

    Report

    Report Number
    3006451981-2011-00081
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 24, 2011
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A LAVH PROCEDURE THE DEVICE WAS STICKY AND WOULD NOT RELEASE TISSUE. FROM THE SURGICAL REPORT IT SAID THE DEVICE WORKED FINE ON THE VARIOUS PEDICULES BUT THAT ON THE LAST BITE, THERE WAS BLEEDING WHICH WAS SIGNIFICANT. THEY TRIED TO CONTROL THE BLEEDING WITH BIPOLAR BUT WERE NOT SUCCESSFUL. BECAUSE OF THE CONTINUED BLEEDING AND SIZE OF THE UTERUS, THEY CONVERTED TO AN OPEN PROCEDURE. THE PT HAS BEEN RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S0M0009

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other