BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIVATORS AUTOMATED SCOPE REPROCESSOR DSD-201

    MDR report key: 1100584 · Received August 5, 2008

    Report

    Report Number
    MW5007903
    Event Type
    Injury
    Date Received
    August 5, 2008
    Report Date
    August 5, 2008
    Manufacturer
    MINNTECH CORP
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CONNECTOR TUBING FROM DEVICE TO ENDOSCOPE POPS OFF DURING HIGH LEVEL DISINFECTION. THERE IS NO ALARM THAT TELLS THE USER THAT THIS HAS HAPPENED THUS THE ENDOSCOPE MAY BE REMOVED FROM THE MACHINE AT THE END OF THE CYCLE WITHOUT THE USER KNOWING THAT DISINFECTANT HAS NOT FLUSHED THRU ALL CHANNELS. THIS COULD CAUSE A CROSS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDIVATORS AUTOMATED SCOPE REPROCESSOR DSD-201 DSD-201 FEB MINNTECH CORP DSD-201

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability