BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1111848 · Received August 13, 2008

    Report

    Report Number
    2084725-2008-00517
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FEB
    PMA / PMN Number
    K832458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESIDUAL FLUID LEFT ON SCOPE - CAPITAL EQUIPMENT, UNIT EVALUATED AT THE FACILITY. THE FSE FOUND THE AIR COMPRESSOR WAS BELOW SPECIFICATIONS. THE FSE REPLACED THE AIR COMPRESSOR. THE FSE CONFIRMED THAT THERE WERE NO LEAKS OR CIDEX OPA LOSS THROUGH THE DRAIN VALUE. THE UNIT THEN FOUND TO BE WITHIN MANUFACTURER SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SEEING "EXCESSIVE AMOUNT OF FLUID ON THE SCOPES" AFTER PROCESSING. THE CUSTOMER STATED THAT THERE WERE NO ERROR MESSAGES FROM THE UNIT. THE CUSTOMER REPORTED THAT THE FLUID APPEARED TO BE A MIXTURE OF WATER AND CIDEX OPA BECAUSE THEY NOTED A SMALL AMOUNT OF STAINING ON THE TOWEL USED TO WIPE THE SCOPE DOWN. THE CUSTOMER STATED THAT THE FLUID WAS NOTED BEFORE THE SCOPE WAS USED ON A PATIENT, NO PATIENT INJURY REPORTED. THE ASP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO ASSESS THE UNIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA CIDEX OPA