BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 3221678 · Received April 15, 2013

    Report

    Report Number
    3006451981-2013-00112
    Event Type
    Malfunction
    Date Received
    April 15, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 22, 2013
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SEAL PLATE OF THE JAWS DISENGAGED FROM THE DEVICE. NOTHING FELL INTO THE PATIENT CAVITY AND THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162199 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S2F0039X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK