BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OES BRONCHOFIBERSCOPE

    MDR report key: 10151763 · Received June 15, 2020

    Report

    Report Number
    8010047-2020-03345
    Event Type
    Malfunction
    Date Received
    June 15, 2020
    Date of Event
    May 15, 2020
    Report Date
    August 26, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K023984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT RETURNED TO OLYMPUS KEYMED (OKM). ACCORDING TO THE EVALUATION BY OKM, FOLLOWING WAS FOUND. OKM CONFIRMED THE REPORTED PHENOMENON. THERE WAS EXCESSIVE HEAT DAMAGE ON THE DISTAL END. THE DISTAL END COVER AND ADHESIVE WARE PARTIALLY MISSING AND METAL WAS EXPOSED. THE DEVICE HISTORY RECORD INDICATES THAT THE SUBJECT DEVICE HAS BEEN SHIPPED IN CONFORMITY TO THE SPECIFICATIONS. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, OMSC CONCLUDED THAT THE DISTAL END WAS HEATED AND DAMAGED DUE TO USER HANDLING.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR 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

    DURING THE THERAPEUTIC OF THE BRANCH WITH ARGON PLASMA COAGULATION, THE USER NOTICED THAT THE DISTAL END CAP AND GLUE OF THE SUBJECT DEVICE FELL OFF. THERE WERE NO REPORTS OF PATIENT INJURIES RELATED TO THIS INCIDENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619104 OES BRONCHOFIBERSCOPE BRONCHOFIBERSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-1T60

    Patients

    Seq Age Sex Outcome Treatment
    1