BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37 CM

    MDR report key: 3772364 · Received February 18, 2014

    Report

    Report Number
    3006451981-2014-00312
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    August 8, 2011
    Report Date
    August 14, 2011
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT WAS RETURNED, EVALUATED AND FOUND TO FUNCTION WITHIN SPECIFICATION. ADDITIONAL TESTING WAS DONE BY PERFORMING MULTIPLE SEALS OF VARIOUS SIZES ON PORCINE TISSUE AND ALL SEAL CYCLES WERE COMPLETED SATISFACTORILY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE SURGEON USED THE DEVICE TO SEAL THE MESENTERY TISSUE, BLEEDING OCCURRED ALTHOUGH THE GENERATOR PROVIDED AN END TONE INDICATING A COMPLETED SEAL CYCLE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102158 LIGASURE ATLAS HANDSWITCHING 37 CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S1C0012PRX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK