BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRONCHOVIDEOSCOPE

    MDR report key: 10732575 · Received October 26, 2020

    Report

    Report Number
    8010047-2020-08105
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    June 12, 2020
    Report Date
    October 25, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    UDI-DI
    04953170342943
    PMA / PMN Number
    K121959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER

    Narratives

    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 (B)(4). THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197267 BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-1TQ170 04953170342943

    Patients

    Seq Age Sex Outcome Treatment
    1