BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS BRONCHOSCOPE

    MDR report key: 1644576 · Received March 25, 2010

    Report

    Report Number
    8010047-2010-00057
    Event Type
    Other
    Date Received
    March 25, 2010
    Date of Event
    January 26, 2010
    Report Date
    March 4, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    EOQ
    PMA / PMN Number
    K023984
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS FORWARDED TO AN INDEPENDENT TEST LABORATORY FOR MICROBIOLOGICAL TESTING. BIOBURDEN TESTING REVEALED NO GROWTH, HOWEVER, THE DEVICE WAS INADVERTENTLY NOT SUBJECTED TO MYCOBACTERIUM TESTING BEFORE BEING ETO STERILIZATION. THE DEVICE WAS FORWARDED TO OLYMPUS FROM THE INDEPENDENT LABORATORY. UPON RECEIPT, THE SWITCH COVER, AND ELECTRICAL CONNECTOR WERE FOUND TO BE PARTIALLY DISASSEMBLED. THE INSTRUMENT CHANNEL WAS EXAMINED VIA BORESCOPE, AND UNIDENTIFIED WHITE PLASTIC FOREIGN OBJECT WAS FOUND INSIDE THE INSTRUMENT CHANNEL, AND WAS SUBSEQUENTLY REMOVED. THERE WERE KINKS IN THE INSTRUMENT CHANNEL NOTED BELOW THE LOCATION WHERE THE FOREIGN OBJECT WAS FOUND. ADDITIONALLY, A WHITE RESIDUE BUILD UP WAS OBSERVED INSIDE THE SUCTION CYLINDER AND AT THE JUNCTION BETWEEN THE BIOPSY PORT AND INSTRUMENT CHANNEL. LONG SCRAPE AND SHEAR MARKS WERE FOUND IN THE INSTRUMENT CHANNEL BELOW THE CHANNEL MOUNT. THE DEVICE FAILED THE LEAK TESTING DUE TO A CUT ON THE INSERTION TUBE RIGHT BELOW THE BOOT. THE UPWARD AND DOWNWARD LEVER KNOB WAS STUCK IN NEUTRAL POSITION DUE TO HARDENED MOLYKOTE ON THE BENDING SECTION MESH. AS PART OF THE INVESTIGATION TO THIS REPORT, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST VISITED THE USER FACILITY AND PROVIDED IN-SERVICE TRAINING ON HOW TO APPROPRIATELY REPROCESS THE DEVICE. BASED UPON THE INFO PROVIDED AND THE RESULTS OF THIS INVESTIGATION, IT APPEARS THAT THE CAUSE OF THE EVENT WAS DUE TO INSUFFICIENT REPROCESSING AND/OR PHYSICAL DAMAGE. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 1

    OCA UNDERTOOK A RETROSPECTIVE REVIEW OF ITS MDR FILES FOR THE PERIOD OF JANUARY 2005 TO APRIL 2015. BASED UPON THIS REVIEW, WE ARE SUBMITTING THIS SUPPLEMENTAL REPORT TO ACCOUNT FOR THE ADDITIONAL SEVEN PATIENTS AS REFERENCED IN THE ORIGINAL REPORT. (B)(4). PLEASE CROSS REFERENCE MFR. REPORT NUMBERS: 2951238-2016-00161, 2951238-2016-00162, 2951238-2016-00163, 2951238-2016-00164, 2951238-2016-00165, 2951238-2016-00166 AND 2951238-2016-00167 TO ACCOUNT FOR THE EIGHT PATIENTS AS REFERENCED IN THE ORIGINAL REPORT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT BRONCHIAL WASHING SAMPLES FROM SIX OUT OF NINE PATIENTS WERE GROWING AFB (ACID FAST BACILLI) FROM FUNGAL CULTURE. ALL NINE PATIENTS WERE EXAMINED USING THE SAME BRONCHOSCOPE. (B)(6)

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE BRONCHIAL WASHING SAMPLES FROM EIGHT OUT OF TEN PATIENTS WERE GROWING ACID-FAST BACILLI (AFB) FROM FUNGAL CULTURE. ALL TEN PATIENTS WERE EXAMINED USING THE SAME BRONCHOSCOPE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other