BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERAII BRONCHOVIDEOSCOPE

    MDR report key: 8548025 · Received April 25, 2019

    Report

    Report Number
    8010047-2019-01845
    Event Type
    Injury
    Date Received
    April 25, 2019
    Report Date
    May 31, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K061313
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) BUT WAS RETURNED TO OLYMPUS EUROPE (OEKG). THE SUBJECT DEVICE WAS SENT TO A THIRD PARTY LABORATORY FOR ADDITIONAL MICROBIOLOGICAL TESTING. IN THE ADDITIONAL TEST, THE TEST RESULT INDICATED NO MICROBIAL GROWTH FOR THE DISTAL END AND THE INSTRUMENT / SUCTION CHANNEL OF THE SUBJECT DEVICE. AFTER THE ADDITIONAL MICROBIOLOGICAL CULTURING TEST BY OLYMPUS EUROPE(OEKG), OEKG EVALUATED THE SUBJECT DEVICE. THE EVALUATION CONFIRMED THAT THE SUBJECT DEVICE PASSED THE LEAKAGE TEST. HOWEVER, THE EVALUATION CONFIRMED FOLLOWING DEFECT. THE ADHESIVE AT THE BENDING SECTION BECAME POROUS AND CHIPPED. THE ADHESIVE AROUND THE OBJECTIVE LENS DID NOT MEET ITS MANUFACTURING SPECIFICATION (IT IS SURMISED THAT THE ADHESIVE WAS USED DURING A REPAIR BY NON-OLYMPUS PARTY). THE INSERTION TUBE WAS SQUEEZED. THE EXACT CAUSE COULD NOT BE CONCLUSIVE DETERMINED. HOWEVER, INAPPROPRIATE REPROCESSING OR MAINTENANCE AT THE USER FACILITY COULD NOT BE RULED OUT AS A FACTOR OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC. OMSC REVIEWED THE MANUFACTURING HISTORY OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE COULD NOT BE DETERMINED AT PRESENT. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING A SURVEILLANCE CULTURING TESTS AT THE USER FACILITY, THE SUBJECT DEVICE TESTED POSITIVE FOR UNSPECIFIED BACTERIA. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION ON THE EVENT. ON APRIL 23, 2019, THE USER FACILITY REPORTED THAT MULTIPLE PATIENTS, WHO UNDERWENT UNSPECIFIED BRONCHOSCOPY BEFORE APRIL 1ST, 2019, WERE FOUND TO BE INFECTED WITH A BACTERIA HAVING SAME STRAINS. ACCORDING TO AN EPIDEMIOLOGICAL RESEARCH INVESTIGATION, THE USER FACILITY CONDUCTED THE SURVEILLANCE CULTURING TEST FOR THE SUBJECT DEVICE AND FOLLOWING BACTERIA WERE DETECTED FROM THE SUBJECT DEVICE. THE BACTERIA DETECTED FROM THE SUBJECT DEVICE ARE THE SAME AS FROM THE PATIENTS. THE SUCTION CHANNEL; S.MARCESCENS (>50CFU/20ML), S.MALTOPHILIA (>50CFU/20ML), CHRSEOBACTERIA(10CFU/20ML) THE INSTRUMENT CHANNEL: S.MARCESCENS (>20CFU/20ML), S.MALTOPHILIA (>20CFU/20ML), CHRSEOBACTERIA(3CFU/20ML). THE FACILITY REPORTED THAT THEY HAD CLEANED THE SUBJECT DEVICE USING AN OLYMPUS CLEANING BRUSH (MODEL MH-507) AND NON-OLYMPUS BRUSH(ENDO-FLEX NEBS41221-G), AND REPROCESSED THE DEVICE USING A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR (GETTINGE ED-FLOW) WITH PERACETIC ACID. DURING THE PRE-CLEANING, THEY HAD NOT FLUSHED THE SUCTION/INSTRUMENT CHANNEL WITH DETERGENT SOLUTION BUT ONLY WITH WATER. THE USER FACILITY DID NOT PROVIDE THE NUMBER OF INFECTED PATIENT AND THE OUTCOMES OF THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344790 EVIS EXERAII BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-1T180

    Patients

    Seq Age Sex Outcome Treatment
    1 Other