BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL TRIO

    MDR report key: 1911099 · Received October 18, 2010

    Report

    Report Number
    1911099
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 18, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    ENSEAL TRIO TISSUE SEALING DEVICE WAS BEING USED DURING SURGERY. THE END OF THE DEVICE BROKE OFF FROM THE REST OF THE DEVICE WHILE THE DEVICE WAS IN THE PATIENT. IT APPEARED TO BE THE LOOP EDGE OF THE DEVICE THAT WAS THE PART THAT BROKE OFF DURING NORMAL USE OF THE DEVICE. THIS PIECE WAS RETRIEVED FROM THE PATIENT AND SEQUESTERED.======================MANUFACTURER RESPONSE FOR ENSEAL TRIO DISPOSABLE TISSUE SEALING DEVICE, ENSEAL TRIO DISPOSABLE TISSUE SEALING DEVICE======================AWAITING RESPONSE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL TRIO TISSUE SEALING DEVICE GEI ETHICON ENDO-SURGERY, LLC NOT APPLICABLE G4TT80;2012-07

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR