BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIVATORS

    MDR report key: 1923506 · Received December 14, 2010

    Report

    Report Number
    2150060-2010-00154
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 18, 2010
    Manufacturer
    MEDIVATORS REPROCESSING SYSTEMS, DIV. OF MINNTECH
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4)-2010, A REPRESENTATIVE FROM OLYMPUS AND (B)(6) HOSPITAL CONTACTED (B)(4) TECHNICAL SERVICE DEPARTMENT, THEY REPORTED POSSIBLE CONTAMINATION WITH (B)(6) WITH TWO ENDOSCOPE REPROCESSORS. THE (B)(4) TECHNICAL SERVICE MANAGER RECOMMENDED THE FACILITY STOP USING BOTH MACHINES UNTIL THE TESTS ARE CONFIRMED. SEVERAL ATTEMPTS WERE MADE FOR THE TEST RESULTS, NO TEST RESULTS RECEIVED FROM THE USER FACILITY AS OF (B)(4)-2010 EXPOSURE OF CJD TO THE AER'S, THE MACHINE FUNCTIONED AS INTENDED.

    Description of Event or Problem · 1

    ON (B)(6)-2010 A REPRESENTATIVE FROM OLYMPUS AND THE USER FACILITY CALLED STATING THAT THEIR ENDOSCOPE REPROCESSORS (2 AER'S ) MAY HAVE BEEN CONTAMINATED WITH (B)(6) DISEASE. THE SCOPE WAS REPROCESSED ON (B)(6)-2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDIVATORS ENDOSCOPE DISINFECTOR FEB MEDIVATORS REPROCESSING SYSTEMS, DIV. OF MINNTECH DSD-2001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other