BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS INJECTION TUBE

    MDR report key: 2818477 · Received October 23, 2012

    Report

    Report Number
    8010047-2012-00406
    Event Type
    Other
    Date Received
    October 23, 2012
    Report Date
    September 25, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FPK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL DETAILS REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT BOTH PTS HAD UNDERGONE THERAPEUTIC ERCP PROCEDURES THAT WERE PERFORMED ON THE SAME FLOOR. ONE PT WAS SAID TO HAVE BEEN CULTURED ON (B)(6) 2012 WHEREAS THE SECOND PT WAS SAID TO HAVE BEEN CULTURED ON (B)(6) 2012 AND BOTH RESULTS WERE POSITIVE FOR MDRO E-COLI. THE REFERENCED DEVICE WAS SAID TO HAVE BEEN CULTURED ON (B)(6) 2012 WITH A POSITIVE CULTURE RESULT FOR E-COLI. BOTH PTS REPORTEDLY WERE PROVIDED WITH ANTIBIOTICS. THE USER FACILITY REPORTED THAT THE INCIDENT MIGHT HAVE BEEN RELATED TO IT'S REPROCESSING PRACTICE AS THE DISPOSABLE CLEANING BRUSHES AND TUBINGS WERE BEING REUSED. OLYMPUS FOLLOWED-UP WITH THE ENDOSCOPY SUPPORT SPECIALIST (ESS) TO OBTAIN ADDITIONAL INFORMATION. THE ESS REPORTED THAT THE USER FACILITY WAS REPROCESSING THE REFERENCED DEVICE AT THE END OF THE DAY ONLY AND WAS REUSING NON-OLYMPUS CHANNEL CLEANING AND CHANNEL OPENING BRUSHES. ADDITIONALLY, CERTAIN PRE-CLEANING STEPS WERE BEING SKIPPED. THE USER FACILITY WAS SAID TO HAVE IMPLEMENTED ALL OLYMPUS REPROCESSING RECOMMENDATIONS HENCE. THIS IS ONE OF FOUR REPORTS. PLEASE ALSO REFERENCE 8010047-2012-00403, 8010047-2012-00404, 8010047-2012-00405. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT TWO PTS HAD BEEN DIAGNOSED WITH CIPRO-RESISTANT E. COLI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS INJECTION TUBE INJECTION TUBE FPK OLYMPUS MEDICAL SYSTEMS CORPORATION MH-946 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1