BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1191294 · Received September 26, 2008

    Report

    Report Number
    2084725-2008-00600
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 2, 2008
    Manufacturer
    MINNTECH COR
    Product Code
    FEB
    PMA / PMN Number
    K832458
    Removal / Correction Number
    2084725-11/12/07-002C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: HOSPITAL WORKER. OTHER, RESIDUAL, OTHER - CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE FOUND UNIT OPERATING PROPERLY. THE FSE SPOKE WITH CUSTOMER AND SHE STATED THAT THEY WERE USING SIX PUMPS OF ENZOL AND REDUCED IT TO FOUR. SINCE THEN SHE HAS NOT SEEN ANY "BLACK SPOTS". SYSTEM IS OPERATING PROPERLY. CONCLUSION: OTHER - THIS ISSUE HAS BEEN ADDRESSED WITH A CUSTOMER LETTER RELATED TO CORRECTION & REMOVAL. REFERENCE MDR 2084725-2008-00601.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE SCOPES WERE REMOVED FROM THE AER AND LAYED ON A TOWEL, SHE REPORTED THAT THERE WERE BLACK SPOTS ON THE TOWEL. THE CUSTOMER DENIES STAINING ON PATIENTS. SHE DENIED STAINING WHEN THE SCOPES ARE HUNG TO DRY AT THE END OF THE DAY. SHE REPORTED THAT THEY ARE USING CIDEX OPA. THE ASP FIELD SERVICE ENGINEER 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 ENDOSCOPE REPROCESSOR FEB MINNTECH COR NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA LOT: UNK| CIDEX OPA| CATALOG: 20390