BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS ENDOSCOPE REPROCESSOR OER-PRO

    MDR report key: 3652380 · Received January 31, 2014

    Report

    Report Number
    2951238-2014-00039
    Event Type
    Other
    Date Received
    January 31, 2014
    Report Date
    January 14, 2014
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    FEB
    PMA / PMN Number
    K103264
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN OLYMPUS FIELD SERVICE ENGINEER WAS DISPATCHED TO THE USER FACILITY. DURING THE ON-SITE EVAL, IT WAS NOTED THAT THE AER WAS NOT DRAINING PROPERLY DUE TO A CRUSHED HOSE. IN ADDITION, THE DISINFECTANT (ACECIDE-C) COULD NOT BE RECOLLECTED, AND WAS DRAINED FROM THE AER DUE TO A CLOGGED CIRCULATION PORT MESH FILTER. THE DEVICE HISTORY LOG WAS REVIEWED, THE FOLLOWING ERRORS WERE NOTED: ERROR E14 (DISINFECTANT SOLUTION CANNOT BE RECOLLECTED) AND E93 (NO ALCOHOL REMAINS). THE AER WAS SERVICED AT THE USER FACILITY. THIS REPORT WILL BE SUPPLEMENTED IF ADD'L INFO BECOMES AVAILABLE AT A LATER TIME. THE INSTRUCTION MANUAL STATES THAT TO ENSURE SAFE, RELIABLE OPERATION, THE MESH FILTERS NEED TO BE CLEANED DAILY.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT A DUODENDOVIDEOSCOPE TESTED POSITIVE FOR KLEBSIELLA PNEUMONIA. THE DUODENDOVIDEOSCOPE WAS REPROCESSED IN THE AUTOMATED ENDOSCOPE REPROCESSOR (AER) PRIOR TO CONDUCTING THE TEST. THE USER FACILITY HAS TWO AER'S AND IT'S UNK IN WHICH ONE THE DUODENDOVIDEOSCOPE WAS REPROCESSED. THERE WAS NO PT INFECTION ASSOCIATED WITH THIS REPORT. OLYMPUS FOLLOWED UP WITH THE USER FACILITY IN AN EFFORT TO OBTAIN ADD'L INFO REGARDING THE REPORTED EVENT. NO ADD'L INFO HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66884 OLYMPUS ENDOSCOPE REPROCESSOR OER-PRO ENDOSCOPE WASHER/DISINFECT FEB OLYMPUS AMERICA, INC. OER-PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other OER-PRO S/N # (B)(4) (2951238-2014-00041)| TJF-Q180V S/N# UNK (2951238-2014-00040)