BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA BRONCHOVIDEOSCOPE

    MDR report key: 10633621 · Received October 6, 2020

    Report

    Report Number
    8010047-2020-07271
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Date of Event
    July 15, 2020
    Report Date
    December 9, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OLYMPUS (BEIJING) SALES & SERVICE CO., LTD.(OCSM) OBTAINED THE ACTUAL PRODUCT AND FOUND THE FOLLOWING. PEELING OFF THE COATING ON THE INSERTION SECTION. PERFORATION / LEAKAGE OF BENDING SECTION. PERFORATION / LEAKAGE OF INSERTION TUBE. LEAKAGE FROM CHANNEL. OMSC REVIEWED THE MANUFACTURE HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE PAST SIMILAR CASES, THERE WAS THE POSSIBILITY THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE FOLLOWING CAUSES. PHYSICAL STRESS OR CHEMICAL STRESS. POOR STORAGE ENVIRONMENT (UNDER DIRECT SUNLIGHT, HIGH TEMPERATURE, HIGH HUMIDITY, ENVIRONMENT EXPOSED TO X-RAYS / ULTRAVIOLET RAYS, ETC.), AGING DETERIORATION.

    Additional Manufacturer Narrative · 1

    SINCE THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR THE EVALUATION, 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 MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT IT WAS FOUND THAT THE COATING OF THE INSERTION TUBE HAD BEEN PARTIALLY PEELED OFF DURING THE INCOMING INSPECTION OF THE SUBJECT DEVICE FOR THE REPAIR AT OLYMPUS CHINA. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102214 EVIS LUCERA BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-1T260

    Patients

    Seq Age Sex Outcome Treatment
    1