BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS BRONCHOSCOPE

    MDR report key: 2470976 · Received February 17, 2012

    Report

    Report Number
    8010047-2012-00039
    Event Type
    Other
    Date Received
    February 17, 2012
    Date of Event
    December 2, 2011
    Report Date
    January 21, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFO REGARDING THE REPORT, AND WAS INFORMED THAT A TOTAL OF 14 PTS HAD BRONCHIAL WASHINGS THAT TESTED POSITIVE WITH (B)(6). THE PTS WERE REPORTEDLY EXAMINED WITH THE SUBJECT DEVICE FROM (B)(6) 2011 TO (B)(6) 2012. USER FACILITY INFECTION CONTROL STAFF REPORTEDLY PERFORMED TESTING AND CULTURED ALL EQUIPMENT IN THE DECONTAMINATION ROOM, INCLUDING THE SUBJECT BRONCHOSCOPE. PER THE USER FACILITY'S INFECTION CONTROL DEPARTMENT, THEY RECOVERED (B)(6) ONLY IN THE SUBJECT BRONCHOSCOPE. THE BRONCHOSCOPE WAS REMOVED FROM SERVICE. ONE OF THE EXAMINED PATIENTS WAS SAID TO HAVE BEEN ADMITTED TO THE HOSPITAL DUE TO UNRELATED ISSUES. THERE WAS NO KNOWN ADDITIONAL TREATMENT PROVIDED TO ANY OF THE EXAMINED PATIENTS. AN OLYMPUS ENDOSCOPE SUPPORT SPECIALIST (ESS) VISITED THE USER FACILITY TO ASSESS REPROCESSING PRACTICES, AND PROVIDED IN-SERVICE TRAINING ON HOW TO PROPERLY REPROCESS THE DEVICE. DURING THE VISIT, THE ESS NOTED NO DEFICIENCIES IN THE REPROCESSING PRACTICES. DURING THE VISIT, THE SUBJECT DEVICE WAS INSPECTED AND THE INSERTION TUBE WAS FOUND TO BE CRUSHED, AND THE SCOPE FAILED LEAK TESTING. A LEAK TESTER AT THE FACILITY WAS FOUND NOT TO BE OPERATING. A LOANER LEAK TESTER WAS PROVIDED, AND THE USER FACILITY WAS ADVISED TO REPEAT LEAK TESTING OF THEIR ENDOSCOPES. THE USER FACILITY WILL REPORTEDLY RETURN THE BRONCHOSCOPE TO OLYMPUS FOR EVALUATION. HOWEVER, THE BRONCHOSCOPE HAS NOT YET BEEN SHIPPED BY THE USER FACILITY. 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 THE BRONCHOSCOPE HAD BEEN CULTURED AND TESTED POSITIVE FOR (B)(6), AND PT HAVE TESTED POSITIVE AS WELL. THERE WAS NO FURTHER INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS BRONCHOSCOPE BRONCHOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORPORATION BF-Q180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS BM-155| OLYMPUS MU-1 MAINTENANCE UNIT