BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 1902991 · Received November 12, 2010

    Report

    Report Number
    3006451981-2010-00094
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 11, 2010
    Report Date
    November 5, 2010
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 EVAL. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    USED MULTIPLE TIMES DURING PROCEDURE - 5TH TIME, CLAMPED AND COAG'ED - BUT COULD NOT RELEASE FROM TISSUE. TORN TISSUE AND SOME BLEEDING WHEN FORCIBLY REMOVED. NO INJURY TO PT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S0C0035

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR