BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL TRIO

    MDR report key: 2024305 · Received March 3, 2011

    Report

    Report Number
    2024305
    Event Type
    Malfunction
    Date Received
    March 3, 2011
    Date of Event
    July 16, 2010
    Report Date
    March 3, 2011
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN ENSEAL DISPOSABLE HAND PIECE FAILED TO WORK. THE WARNING LIGHT ON THE ENSEAL UNIT STATED THAT THE HAND PIECE WAS DEFECTIVE. A SECOND HAND PIECE WITH THE SAME LOT NUMBER FAILED TO WORK AND THE WARNING LIGHT ON THE ENSEAL UNIT STATED THAT THE HAND PIECE WAS DEFECTIVE. A THIRD HAND PIECE WITH A DIFFERENT LOT NUMBER WAS OPENED AND SUCCESSFULLY USED FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL TRIO TISSUE SEALING DEVICE GEI ETHICON ENDO-SURGERY * 647C14
    2 ENSEAL TRIO TISSUE SEALING DEVICE GEI ETHICON ENDO-SURGERY * 647C14

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR