BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA BRONCHOVIDEOSCOPE

    MDR report key: 2190047 · Received June 29, 2011

    Report

    Report Number
    8010047-2011-00141
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Report Date
    June 1, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORT, AND WAS INFORMED THAT THERE WERE TWO PT BRONCHOALVEOLAR LAVAGE (BAL) SAMPLES CULTURED POSITIVE FOR AN UNSPECIFIED MICROORGANISM. THE NURSE MANAGER AT THE USER FACILITY REPORTED THAT THE SUBJECT DEVICE WAS CULTURED POSITIVE WITH (B)(6) SPECIES AFTER IT WAS REFURBISHED BY OLYMPUS ON (B)(4), 2011 AND BEFORE IT WAS RETURNED TO OLYMPUS FOR EVALUATION OF THIS COMPLAINT. HOWEVER, THE NURSE MANAGER INDICATED THAT THERE WAS NO PT INFECTION OR NO PT HARM ASSOCIATED WITH THIS REPORT. THE PTS WERE NOT PROVIDED MEDICATION. THE DEVICE REFERENCE IN THIS REPORT WAS FORWARDED TO AN INDEPENDENT MICROBIOLOGY LABORATORY FOR MICROBIOLOGICAL TESTING. TEST RESULTS FROM THIS TESTING WAS NEGATIVE. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION DID NOT DUPLICATE THE USERS REPORT OF DIFFICULTY PASSING THE CLEANING BRUSH AT THE BENDING SECTION AREA. THE DEVICE WAS TESTED USING AN OLYMPUS BIOPSY FORCEPS MODEL FB-19C AND CLEANING BRUSH MODEL BW-15B, AND THERE WAS NO RESTRICTIONS FOUND. THERE WAS NO EVIDENCE OF FOREIGN/BIOMATERIAL, STAIN, AND RESIDUE IN THE INSTRUMENT CHANNEL. THE DEVICE PASSED THE LEAK TEST. THE DEVICE WAS SERVICED AND WAS RETURNED TO THE USER FACILITY. AS PART OF OUR INVESTIGATION, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST WAS DISPATCHED TO THE USER FACILITY TO REASSESS THE USER FACILITY'S REPROCESSING PRACTICES AND PROVIDE REPROCESSING INSERVICE AND TRAINING IF NECESSARY. THIS REPORT IS BEING SUBMITTED AS MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEY EXPERIENCED DIFFICULTY PASSING AN UNSPECIFIED CLEANING BRUSH AT THE BENDING SECTION AREA OF THE ENDOSCOPE. THE USER FACILITY REPORTED AN ODD BACTERIAL CULTURE ON THE PT'S BRONCHOALVEOLAR LAVAGE SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA BRONCHOVIDEOSCOPE BRONCHOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP BF-P160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1