BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 3170018 · Received June 10, 2013

    Report

    Report Number
    MW5030529
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 18, 2011
    Report Date
    May 22, 2013
    Manufacturer
    OLYMPUS
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, DURING A REVIEW OF CLEANING PROCESS FOR COLONOSCOPIES, IT WAS DISCOVERED THAT THE FINAL STEP FOR HIGH LEVEL DISINFECTION WAS NOT BEING PERFORMED. STAFF HAD BEEN TRAINED WITH THE ATTACHED ENDOSCOPE CLEANING GUIDE, WHICH INCLUDES NUMERIC STEP-BY-STEP INSTRUCTIONS, BUT MAKES ONLY CURSORY MENTION OF "APPROPRIATE HIGH-LEVEL DISINFECTION." THE INSTRUCTIONS, AS ATTACHED WERE INCOMPLETE AND CONFUSING TO STAFF, RESULTING IN FAILURE TO PERFORM ALL NECESSARY STEPS IN THE PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261539 OLYMPUS VIDEO COLONOSCOPE FDF OLYMPUS CF-Q140L NA
    261540 OLYMPUS VIDEO COLONOSCOPE FDF OLYMPUS PCF-140J NA

    Patients

    Seq Age Sex Outcome Treatment
    1