BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL TRIO

    MDR report key: 3062832 · Received April 8, 2013

    Report

    Report Number
    3062832
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 29, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE DEVICE BROKE OFF. THE EQUIPMENT WAS REMOVED TO BE CLEANED, AND BE SENT FOR EVALUATION.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?UNKNOWN.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143014 ENSEAL TRIO ELECTROSURGICAL, CUTTING, COAGULATION GEI ETHICON ENDO-SURGERY, INC. ETRIO 335H *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR