BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAUTERY UNIT

    MDR report key: 2941017 · Received October 17, 2006

    Report

    Report Number
    2941017
    Event Type
    Malfunction
    Date Received
    October 17, 2006
    Date of Event
    July 12, 2006
    Report Date
    October 10, 2006
    Manufacturer
    PENTAX MEDICAL CO.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT A COLONOSCOPY. AFTER PROCEDURE WAS COMPLETED PATIENT WAS ADMITTED TO THE EMERGENCY ROOM FOR SEVERE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAUTERY UNIT NONE GEI PENTAX MEDICAL CO. CGI-4000

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR