BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELON PROBREATH

    MDR report key: 3121581 · Received May 17, 2013

    Report

    Report Number
    3121581
    Event Type
    Malfunction
    Date Received
    May 17, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 17, 2013
    Manufacturer
    SURETEK MEDICAL
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A TONSILLECTOMY THE CELON BREATH PROBE WOULD NOT WORK FOR THE DOCTOR.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?TONSILLECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218936 CELON PROBREATH ELECTROSURGICAL, CUTTING AND COAGULATION GEI SURETEK MEDICAL 1.1MMX 100MM 0-25WATT 00130323

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR