BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL PTC TRIO

    MDR report key: 1770090 · Received July 22, 2010

    Report

    Report Number
    1770090
    Event Type
    Malfunction
    Date Received
    July 22, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 22, 2010
    Manufacturer
    SURGRX INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE ENSEAL DEVICE, IT STOPPED WORKING. AN ALARM SOUNDED AND THE MACHINE PROMPTED "REPLACE." THE HAND PIECE WAS REPLACED AND WORKED PROPERLY.====================== HEALTH PROFESSIONAL'S IMPRESSION======================ALTHOUGH NO HARM WAS DONE TO THE PATIENT, A DELAY IN THE CASE OCCURRED WHILE THE PATIENT WAS UNDER ANESTHESIA TO TROUBLESHOOT AND THEN REPLACE THE HAND PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL PTC TRIO TISSUE SEALING DEVICE GEI SURGRX INC * F09A20-01
    2 ENSEAL PTC TRIO TISSUE SEALING DEVICE GEI SURGRX INC * F09A20-01

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR