BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA BRONCHOVIDEOSCOPE

    MDR report key: 12876357 · Received November 25, 2021

    Report

    Report Number
    8010047-2021-15098
    Event Type
    Malfunction
    Date Received
    November 25, 2021
    Date of Event
    October 28, 2021
    Report Date
    December 25, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. THE EVALUATION IS IN PROGRESS CURRENTLY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED ON THE REPORTED INFORMATION, IT IS PRESUMED AS FOLLOWS. AS A RESULT OF ANALYZING THE BLUE-GREEN DEPOSITS, WE CONFIRMED THAT THE MAIN COMPONENT OF THE DEPOSITS WAS VERY SIMILAR TO DISINFECTANT OF PERACETIC ACID IN FT-IR. IN ADDITION, O (OXYGEN), CU (COPPER), AND ZN (ZINC) WERE STRONGLY DETECTED IN EDX, AND THE FOREIGN MATTER WAS GREEN, SUGGESTING THAT BRASS (COPPER / ZINC ALLOY) MAY BE DERIVED FROM RUST. THE MATERIAL USED TO FIX THE TUBE IS BRASS, AND IT TURNED GREEN. THEREFORE, IT IS PRESUMED THAT THIS PHENOMENON CAUSED WATER TO ENTER THE SCOPE FROM THE AIR LEAK POINT OF THE CHANNEL BUCKLING, THE INTERNAL PARTS CORRODED, AND THE CORRODED LIQUID CAME OUT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING THE UNSPECIFIED TIMING, IT WAS FOUND THAT BLUE-GREEN LIQUID CAME OUT FROM THE DISTAL END OF THE SUBJECT DEVICE. THE SUBJECT DEVICE HAD BEEN STORED IN THE CABINET AFTER THE REPROCESS WITH AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL OER-5 (NOT AVAILABLE IN THE USA). THERE WAS NO ABNORMALITY IMMEDIATELY AFTER THE REPROCESS, THE ISSUE WAS FOUND AFTER MORE ONE WEEK SINCE THE REPROCESS. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773489 EVIS LUCERA BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-F260

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown