BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERAII BRONCHOVIDEOSCOPE

    MDR report key: 11684121 · Received April 19, 2021

    Report

    Report Number
    8010047-2021-05095
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Report Date
    May 12, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K061313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, BECAUSE THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC). HOWEVER, BASED UPON THE PAST SIMILAR CASES, THE REPORTED EVENT MAY HAVE BEEN CAUSED BY THE APPLICATION OF SOME PHYSICAL OR CHEMICAL STRESS TO THE INSERTION SECTION. EXAMPLES INCLUDE PHYSICAL STRESS SUCH AS RUBBING THE INSERTION SECTION, CHEMICAL STRESS DUE TO DEVIATION FROM THE REPROCESSING MANUAL, POOR STORAGE ENVIRONMENT SUCH AS DIRECT SUNLIGHT, HIGH TEMPERATURE, HIGH HUMIDITY, X-RAYS AND ULTRAVIOLET RAYS, AGING DETERIORATION, ETC. THE INSTRUCTION MANUAL PROVIDES WARNINGS ABOUT APPLYING EXTERNAL STRESS TO THE INSERTION SECTION, REPROCESSING METHOD NOT RECOMMENDED BY THE REPROCESSING MANUAL, AND STORAGE OF THE ENDOSCOPE IN A HARSH ENVIRONMENT. DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) BUT WAS RETURNED TO OCG FOR EVALUATION. OCG INSPECTED THE DEVICE AND CONFIRMED THE FOLLOWING; THERE WAS A LEAKAGE AT THE INSTRUMENT CHANNEL DUE TO PERFORATION. THE LENS ADHESIVE OF THE DISTAL END WAS WORN. THE ADHESIVE OF THE BENDING SECTION RUBBER WAS DEFECTIVE. THE INSERTION TUBE WAS DEFORMED. THE UNIVERSAL CORD AND GRIP UNIT WERE SCRATCHED. THE REPORTED EVENT MAY HAVE BEEN CAUSED BY USER'S HANDLING. 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.

    Description of Event or Problem · 1

    OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) AND FOUND THAT THE COATING OF THE INSERTION TUBE GREATER THAN 1X1 SQUARE MILLIMETER HAD BEEN PEELED OFF. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586141 EVIS EXERAII BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-Q180

    Patients

    Seq Age Sex Outcome Treatment
    1