BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL TRIO

    MDR report key: 1668654 · Received April 22, 2010

    Report

    Report Number
    1668654
    Event Type
    Malfunction
    Date Received
    April 22, 2010
    Date of Event
    April 6, 2010
    Report Date
    April 22, 2010
    Manufacturer
    SURGRX, INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    AS SURGEON ATTEMPTED TO USE ENSEAL DISPOSABLE TISSUE SEALING DEVICE, AN ERROR MESSAGE WAS GIVEN ON THE GENERATOR TO REPLACE THE HANDLE. THE HANDLE WAS REPLACED WITH THE SAME PRODUCT AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL TRIO TISSUE SEALING DEVICE GEI SURGRX, INC * F4PH1C

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR