BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALYMPUS EVIS EXERA II BRONCHOVIDEOSCOPE

    MDR report key: 2591876 · Received May 17, 2012

    Report

    Report Number
    8010047-2012-00158
    Event Type
    Other
    Date Received
    May 17, 2012
    Report Date
    April 18, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST HAS VISITED THIS FACILITY AND PROVIDED TRAINING ON THE APPROPRIATE REPROCESSING OF ENDOSCOPES. NO PRODUCTS WERE RETURNED TO OLYMPUS FOR EVAL. IF ADD'L AND SIGNIFICANT INFO BECOMES AVAILABLE AT A LATER TIME, THEN THIS REPORT WILL BE SUPPLEMENTED. OLYMPUS INSTRUCTION AND REPROCESSING MANUALS PROVIDE DETAILED INFO ON HOW TO REPROCESS ENDOSCOPES. THE CAUSE OF THIS REPORT APPEARS TO BE DUE TO USER ERROR. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE USER FACILITY WAS NOT REPROCESSING THE BRONCHOSCOPES IN ACCORDANCE WITH THE DIRECTIONS FOR USE. THE USER FACILITY PERSONNEL HAD REPORTEDLY CONNECTED TO OLYMPUS MAJ-222 SUCTION CLEANING ADAPTOR FROM THE BRONCHOSCOPE TO A MEDIVATOR RESTRICTION PLUG AND TO A MEDIVATOR DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR. ADDITIONALLY, THE USER FACILITY REPORTEDLY WAS NOT CONNECTING THE MAJ-222 SUCTION CLEANING ADAPTOR TO THE REFERENCED DEVICE DURING MANUAL CLEANING, BUT WAS SAID TO HAVE BEEN PERFORMING PRE-CLEANING, LEAKAGE TESTING, AND MANUAL CLEANING. THERE HAD BEEN NO REPORT OF INFECTION AND CROSS CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALYMPUS EVIS EXERA II BRONCHOVIDEOSCOPE BRONCHOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORPORATION BF-1T180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS MAJ-222 SUCTION CLEANING ADAPTOR| MEDIVATOR DSD-201 WITH UNK SERIAL NUMBER