BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL

    MDR report key: 3092161 · Received April 29, 2013

    Report

    Report Number
    MW5030018
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 29, 2013
    Manufacturer
    ENSEAL
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENSEAL DEVICE REF # NSEAL535RH WAS DEFECTIVE. INSTRUMENT WOULD NOT HOLD TISSUE EFFECTIVELY WHEN BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184681 ENSEAL CAUTERY DEVICE GEI ENSEAL NSEAL535RH

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR