BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERAII BRONCHOVIDEOSCOPE

    MDR report key: 9698447 · Received February 12, 2020

    Report

    Report Number
    8010047-2020-01242
    Event Type
    Injury
    Date Received
    February 12, 2020
    Report Date
    April 13, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K061313
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO OLYMPUS EUROPA SE & CO. KG. (OEKG). OEKG SENT THE DEVICE TO A THIRD PARTY LABORATORY FOR MICROBIOLOGICAL TESTING. AS A RESULT OF THE TESTING, NO MICROBE WAS DETECTED FROM THE SAMPLE COLLECTED FROM THE DISTAL END AND INSTRUMENT CHANNEL OF THE SUBJECT DEVICE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. IN THE EVALUATION OF OEKG THE FOLLOWING WAS CONFIRMED, BUT THE CAUSAL RELATIONSHIP THE REPORTED EVENT WAS UNKNOWN. (1) BF-Q180 (SERIAL NUMBER (B)(4)). - THE DISTAL END COVER WAS DAMAGED. - THE INSERTION TUBE WAS DEFORMED AND KINKED. (2) BF-UC180F (SERIAL NUMBER (B)(4)). - BETWEEN THE DISTAL END AND BENDING SECTION WAS LOOSEN. - THE INSERTION TUBE WAS KINKED. - THE LIGHT GUIDE TUBE WAS SCRATCHED. - THERE WAS THE POSSIBILITY THAT THE SCOPE CONNECTOR HAD BEEN REPAIRED BY A THIRD PARTY. - THE ULTRASOUND IMAGE WAS FAILED DUE TO SOUND WIRES BROKEN. - THE ENDOSCOPIC IMAGE WAS DISTURBED. - THE IMAGE FIBER WAS DAMAGED. (3) BF-1TH190 (SERIAL NUMBER (B)(4)). - THE LIGHT GUIDE LENS WAS SCRATCHED. - THE INSERTION TUBE WAS DEFORMED AND CORRODED. - THE PLUG UNIT CONTACT AND THE VENTING CONNECTOR WERE CORRODED. (4) BF-1T60 (SERIAL NUMBER (B)(4). - THE DISTAL END COVER WAS DAMAGED. - THE BENDING SECTION WAS DEFORMED. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THE BACTERIA MYCOBACTERIUM LENTIFLAVUM WHICH HAD BEEN IDENTIFIED IN THE MICROBIOLOGICAL TESTING OF THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE BY THE USER FACILITY WAS SAME AS THE BACTERIA WHICH WAS IDENTIFIED IN THE SAMPLE COLLECTED FROM THE PATIENTS. OTHER DETAILED INFORMATION SUCH AS THE NUMBER OF MICROBES WAS NOT PROVIDED. ALSO, OMSC RECEIVED INFORMATION FROM THE USER FACILITY THAT THE NUMBER OF INFECTED PATIENTS WAS 54, NOT 36. THEREFORE OMSC IS SUBMITTING 54 MEDICAL DEVICE REPORTS ACCORDING TO THE NUMBER OF THE INFECTED PATIENTS. THIS IS 12 OF THE 54 REPORTS.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT 36 PATIENTS WERE INFECTED WITH MYCOBACTERIUM LENTIFLAVUM. THE FACILITY OWNS OLYMPUS BRONCHOVIDEOSCOPE MODEL BF-Q180 (SERIAL NUMBER: (B)(4)), BF-UC180F (SERIAL NUMBER: (B)(4)), BF-1TH190 (SERIAL NUMBER: (B)(4)) AND BF-1T60 (SERIAL NUMBER: (B)(4)), AND MAY HAVE BEEN USED FOR THESE PATIENTS, BUT IT IS UNKNOWN WHICH SCOPE WAS USED FOR WHICH PATIENT. THE DEVICES HAD BEEN REPROCESSED WITH AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL MINIETD2 (NOT AVAILABLE IN THE USA). OTHER DETAILED INFORMATION SUCH AS THE OUTCOME OF PATIENTS WAS NOT PROVIDED. OMSC IS SUBMITTING 36 MEDICAL DEVICE REPORTS ACCORDING TO THE NUMBER OF THE INFECTED PATIENTS. THIS IS 12 OF THE 36 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165220 EVIS EXERAII BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other