BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1083508 · Received July 29, 2008

    Report

    Report Number
    2084725-2008-00421
    Event Type
    Injury
    Date Received
    July 29, 2008
    Report Date
    June 26, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FEB
    PMA / PMN Number
    K832458
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING FSE EVAL OF UNIT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN "ADULT" PT EXPERIENCED "ACQUIRED COLITIS" AFTER AN ENDOSCOPIC PROCEDURE WITH AN OLYMPUS SCOPE PROCESSED IN THE AER WITH CIDEX OPA. NO ADD'L PT INFO WAS PROVIDED. THE PHYSICIAN REPORTED THAT HE BELIEVED THAT THIS WAS "INDICATIVE OF OPA BEING LEFT IN THE SCOPES AFTER PROCESSING IN THE AER". THE CUSTOMER REPORTED THAT THEY ARE NOT PERFORMING AN ALCOHOL FLUSH AFTER EACH WASH AND DISINFECT CYCLE AS RECOMMENDED BY THE USER'S GUIDE. ATTEMPTED TO CONTACT THE CUSTOMER FOR FURTHER INFO, BUT THE CUSTOMER WAS NOT AVAILABLE. AWAITING THE REPORT FROM THE ASP FIELD SVC ENGINEER (FSE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER ENDOSCOPE REPROCESSOR FEB ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CIDEX OPA