BEUDAMED
    FDA Adverse Event Other Summary report: N

    MINNTECH

    MDR report key: 1842522 · Received September 20, 2010

    Report

    Report Number
    MW5017492
    Event Type
    Other
    Date Received
    September 20, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 19, 2010
    Manufacturer
    MINNTECH CORP
    Product Code
    FEB
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WE ARE WRITING TO ADVISE YOU OF A DEVELOPMENT THAT OCCURRED RELATED TO ENDOSCOPY PROCEDURES PERFORMED AT (B)(6) IN 2010. THE DISTRIBUTOR OF THE REPROCESSORS RECOMMENDED IN A LETTER DATED 02/19/2010 THAT THE HEATING ELEMENT OF THE REPROCESSORS BE DISCONNECTED. IT ALSO PROVIDED SOME INFO ABOUT USE OF HIGH LEVEL DISINFECTANTS. THE HEATING ELEMENT WAS DISCONNECTED ON (B)(6)2010, WITH NO CHANGE IN THE DISINFECTION SOAK TIME. WE ARE ACTIVELY INVESTIGATING THE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINNTECH AUTOMATIC ENDOSCOPE REPROCESSOR FEB MINNTECH CORP
    10 OLYMPUS ENDOSCOPE KOG OLYMPUS AMERICA INC. PCF-Q180AL NA
    11 OLYMPUS ENDOSCOPE KOG OLYMPUS AMERICA INC. PCF-Q180AL NA
    12 OLYMPUS ENDOSCOPE KOG OLYMPUS AMERICA INC. PCF-Q180AL NA
    13 OLYMPUS ENDOSCOPE KOG OLYMPUS AMERICA INC. PCF-Q180AL NA
    14 OLYMPUS ENDOSCOPE KOG OLYMPUS AMERICA INC. PCF-Q180AL NA
    15 OLYMPUS ENDOSCOPE KOG OLYMPUS AMERICA INC. PCF-Q180AL NA
    16 OLYMPUS ENDOSCOPE KOG OLYMPUS AMERICA INC. PCF-Q180AL NA
    17 OLYMPUS ENDOSCOPE KOG OLYMPUS AMERICA INC. PCF-Q180AL NA
    18 OLYMPUS ENDOSCOPE KOG OLYMPUS AMERICA INC. GIF-H180 NA
    19 OLYMPUS ENDOSCOPE KOG OLYMPUS AMERICA INC. GIF-H180 NA
    2 MINNTECH AUTOMATIC ENDOSCOPE REPROCESSOR FEB MINNTECH CORP
    3 METRICIDE OPA PLUS SOLUTION NA MED METREX
    4 OLYMPUS ENDOSCOPE KOG OLYMPUS AMERICA INC. CH-H180AL NA
    5 OLYMPUS ENDOSCOPE KOG OLYMPUS AMERICA INC. CH-H180AL NA
    6 OLYMPUS ENDOSCOPE KOG OLYMPUS AMERICA INC. CH-H180AL NA
    7 OLYMPUS ENDOSCOPE KOG OLYMPUS AMERICA INC. CH-H180AL NA
    8 OLYMPUS ENDOSCOPE KOG OLYMPUS AMERICA INC. CH-H180AL NA
    9 OLYMPUS ENDOSCOPE KOG OLYMPUS AMERICA INC. CH-H180AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA