BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 3861909 · Received February 14, 2014

    Report

    Report Number
    3006451981-2014-00153
    Event Type
    Injury
    Date Received
    February 14, 2014
    Date of Event
    July 8, 2010
    Report Date
    July 20, 2010
    Manufacturer
    COVIDIEN LLC
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT SENT: (B)(4) 2010 UNDER MDR NUMBER 1717344-2010-00505.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A C.R. RESECTION. THE SURGEON ACTIVATED THE INSTRUMENT BUT A SEAL WAS NOT CREATED. WHEN THE SURGEON CUT WITH THE BLADE OF THE DEVICE, THERE WAS BLEEDING. A SECOND LS1037 WAS OPENED AND THE SAME THING HAPPENED. SEE MFR REPORT # 1717344-2010-00506. THE PROCEDURE WAS INITIALLY LAPAROSCOPIC BUT IT WAS CONVERTED TO OPEN DUE TO THE FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97837 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC S0A0004

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention FORCETRIAD-ELECTROSURGICAL GENERATOR S/N (B)(4)