BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOTHERAPY CATHETER

    MDR report key: 2687832 · Received August 4, 2012

    Report

    Report Number
    2687832
    Event Type
    Malfunction
    Date Received
    August 4, 2012
    Date of Event
    June 1, 2012
    Report Date
    August 4, 2012
    Manufacturer
    GI SUPPLY
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CATHETER WOULD NOT OPERATE ("FIRE"). SWAPPED FOR ANOTHER (DIFFERENT LOT NUMBER) AND WORKED IMMEDIATELY. DELAY ONLY. NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOTHERAPY CATHETER CRYOTHERAPY CATHETER GEH GI SUPPLY N/A PW1202

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR