BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 2379415 · Received December 12, 2011

    Report

    Report Number
    MW5023460
    Event Type
    Malfunction
    Date Received
    December 12, 2011
    Date of Event
    November 28, 2011
    Report Date
    December 12, 2011
    Manufacturer
    PENTAX MEDICAL COMPANY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN USING CAUTERIZATION, THE UNIT ON THE TRAVEL CART WOULD NOT FIRE. NEW UNIT HAD TO BE BROUGHT UP AND PROCEDURE WAS FINISHED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTAX PENTAX CAUTERY DEVICE CGI - 4000 GEI PENTAX MEDICAL COMPANY CGI-4000

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR