BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 3040970 · Received October 4, 2005

    Report

    Report Number
    8010047-2005-00135
    Event Type
    Malfunction
    Date Received
    October 4, 2005
    Manufacturer
    OLYMPUS OPTICAL CO. LTD.
    Product Code
    FDS
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE #2. REFERENCE REPORTS: 8010047-2005-00109, 00136 - 00143. THE USER FACILITY DETERMINED 10 OLYMPUS ENDOSCOPES IN TOTAL WERE REPROCESSED IN THE SUBJECT AER. THE ENDOSCOPES IN QUESTION WERE NOT RETURNED TO OLYMPUS FOR INVESTIGATION AS THE USER FACILITY DETERMINED THE ROOT CAUSE WAS THE INCORRECT SETTINGS ON THEIR AER. THEREFORE, BASED ON THE INFORMATION PROVIDED BY THE USER FACILITY, THIS REPORT IS BEING FILED AS AN MDR DUE TO APPARENT USER ERROR ASSOCIATED WITH FAILURE TO FOLLOW AUTOMATED ENDOSCOPE REPROCESSOR INSTRUCTIONS. SUCH FAILURE MAY HAVE ALLOWED THE ENDOSCOPES TO BECOME CONTAMINATED.

    Description of Event or Problem · 1

    ON (B)(6) 2005 IT WAS DISCOVERED THAT THE SETTINGS ON ONE OF THE USER FACILITIES AUTOMATED ENDOSCOPE REPROCESSORS (AER) HAD BEEN REVERSED. THE CORRECT SETTINGS ARE A FIVE MINUTE WASH AND A TWENTY MINUTE DISINFECTION SOAK. ON (B)(6), THE SETTINGS WERE VERIFIED AS CORRECT. ON (B)(6), THE AER WAS EXPERIENCING A PRINTER FAILURE. THE SERVICE TECHNICIAN FOR THE AER VISITED THE USER FACILITY THE NEXT DAY, DIAGNOSED THE PROBLEM AND ORDERED A REPLACEMENT. THE REPLACEMENT ARRIVED WAS PUT INTO SERVICE (B)(6). A PRINT-OUT OF WASH AND DISINFECTION CYCLES WAS MADE AT THAT TIME. HOWEVER, IT WAS NOT UNTIL (B)(6), THAT THE PRINT-OUT WAS READ AND THE DISCOVERY MADE THAT THE AER HAD BEEN REPROCESSING ENDOSCOPES WITH A TWENTY MINUTE WASH AND FIVE MINUTE DISINFECTION CYCLE TIME. THE AER WAS IMMEDIATELY TAKEN OUT OF SERVICE AND PROGRAMMED TO THE CORRECT SETTINGS. A REVIEW OF PT PROCEDURES REVEALED THAT ENDOSCOPES REPROCESSED IN THE SUBJECT AER FROM (B)(6) WERE USED ON APPROXIMATELY 90 PTS. ALL PT HAVE BEEN CONTACTED AND TESTED FOR (B)(6). THE RESULTS OF THE TESTING WERE NOT DISCLOSED. ALL PTS WILL BE TESTED AGAIN IN SIX MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS OPTICAL CO. LTD. GIF-Q160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK