BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 20CM

    MDR report key: 1082354 · Received July 24, 2008

    Report

    Report Number
    1717344-2008-00340
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 30, 2008
    Manufacturer
    COVIDIEN LP (US SURGICAL)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT ON THE 3RD SEALING OF THE MESENTERIUM IN A BOWEL ILEUS PROCEDURE THE DEVICE BECAME STICKY. WHEN THE DEVICE WAS REMOVED, BOTH EDGES OF THE TISSUE WERE SUTURED TO ASSURE THE SEAL. ANOTHER DEVICE WAS OPENED AND USED TO COMPLETE THE SURGERY. THERE WAS NO BLEEDING AND NO TISSUE WAS DAMAGED. THE GENERATOR WAS SET AT 2 BARS. NO PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS HANDSWITCHING 20CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (US SURGICAL) N7C206

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LIGASURE VESSEL SEALING GENERATOR