BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 1870376 · Received October 12, 2010

    Report

    Report Number
    3006451981-2010-00082
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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 THEY HAD DIFFICULTY IN RELEASING THE TISSUE AFTER APPLICATION OF THE DEVICE DURING A LAPAROSCOPIC OOPHORECTOMY PROCEDURE. THERE WAS NO TISSUE DAMAGE OR PT INJURY. THIS DID NOT CAUSE MORE THAN 250CC OF UNANTICIPATED BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S0D0035

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK