BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRONCHOVIDEOSCOPE

    MDR report key: 12530950 · Received September 26, 2021

    Report

    Report Number
    8010047-2021-12267
    Event Type
    Malfunction
    Date Received
    September 26, 2021
    Report Date
    January 10, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    UDI-DI
    04953170288968
    PMA / PMN Number
    K023984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS INSPECTED AT OLYMPUS INDIA. IT WAS CONFIRMED THAT THE COATING OF THE INSERTION TUBE OF THE SUBJECT DEVICE WAS PEELED OFF MORE THAN 1MM2 DUE TO DETERIORATION. IN ADDITION, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) CHECKED THE INSPECTION REPORT AND ITS PHOTO OF OLYMPUS INDIA. IT WAS FOUND A SIGN OF INSUFFICIENT OR INCORRECT REPROCESSING THE SUBJECT DEVICE THAT THE FOREIGN MATERIAL REMAINED ON THE INSERTION SECTION OF THE SUBJECT DEVICE (THE USER MAY HAVE USED THE POOR REPROCESSING SUBJECT DEVICE FOR NEXT PROCEDURE). OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. [CONCLUSION] THE CAUSES OF THE REPORTED PHENOMENA COULD NOT BE IDENTIFIED. [CONSIDERATIONS] COATING OF THE INSERTION SECTION WAS PEELING OFF AS A CAUSE, IT WAS PRESUMED PHYSICAL STRESS AND CHEMICAL STRESS OR BAD STORAGE ENVIRONMENT (SUCH AS IN DIRECT SUNLIGHT, AT HIGH TEMPERATURES, IN HIGH HUMIDITY, OR EXPOSED TO X-RAYS AND/OR ULTRAVIOLET-RAYS) OR THE LIKE WAS PRESUMED. FOREIGN MATERIAL LEFT ON THE INSERTION SECTION IT WAS PRESUMED IMPROPER REPROCESSING AT THE USER FACILITY AS A CAUSE. ACCORDING TO THE FORMER SIMILAR CASES, THE PROBABLE CAUSES HAD BEEN INSUFFICIENT REPROCESSING AND RESIDUE IN GAP DUE TO CHEMICAL STRESS FROM REPROCESSING. THE REPORTED PHENOMENA, THE COATING OF THE SUBJECT DEVICE WAS PEELING OFF WAS PRESUMABLY DUE TO THE SAME CAUSE. IT WAS FOUND BROWN RESIDUE ON THE INSERTION SECTION FROM THE INSPECTION REPORT OF OLYMPUS INDIA. ORIGIN OF THE RESIDUE COULD NOT BE IDENTIFIED. THE SUBJECT DEVICE WAS DIRTY THROUGHOUT. DUE TO USER¿S INSUFFICIENT REPROCESSING, SOME FOREIGN MATERIAL MAY HAVE ADHERED TO GAP GENERATED BY PEELED COATING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS (B)(4) BUT HAS NOT RETURNED TO OMSC. THE SUBJECT DEVICE IS CURRENTLY UNDERGOING EVALUATION AT OLYMPUS (B)(4). 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.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT OLYMPUS (B)(4), IT WAS FOUND THAT THE INSERTION TUBE OF THE SUBJECT DEVICE WAS PEELED OFF MORE THAN 1MM2. THE OCCURRENCE DATE OF THE EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428541 BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-1T150 04953170288968

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown