BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 2980505 · Received January 31, 2013

    Report

    Report Number
    3006451981-2013-00017
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    December 13, 2012
    Report Date
    January 7, 2013
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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 THE JAWS OF THE DEVICE WOULD NOT OPEN AND BECAME STUCK. THE SITE CONTACT DOES NOT KNOW IF THE DEVICE WAS ON TISSUE AT THE TIME. THERE WAS NO PT INJURY AND THE SURGEON USED A 2ND DEVICE TO COMPLETE THE PROCEDURE. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41944 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S2D0016X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK