BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERAII BRONCHOVIDEOSCOPE

    MDR report key: 11159958 · Received January 13, 2021

    Report

    Report Number
    8010047-2021-01274
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Report Date
    February 16, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K061313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION BUT WAS RETURNED TO OLYMPUS EUROPE SE & CO. KG (OEKG). DURING THE INCOMING INSPECTION, OEKG CONFIRMED THE REPORTED PHENOMENA THAT THE DISTAL END COVER WAS CRACKED AND PARTIALLY MISSING. THE SUBJECT DEVICE DID NOT PASS THE AIR LEAK TEST DUE TO FAILURE IN THE INSTRUMENT CHANNEL AND THE BENDING RUBBER. OEKG FOUND DEEP SCRATCHES IN THE INSERTION SECTION AND THE UNIVERSAL CORD, CRACK IN THE ANGULATION LEVER, INSERTION/WITHDRAWAL FAILURE IN THE INSTRUMENT CHANNEL, AND POOR PERFORMANCE OF SUCTIONING. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED ON THE INSPECTION, THERE IS THE POSSIBILITY THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO PHYSICAL STRESS DUE TO DEVICE HANDLING OF THE USER OR THERMAL DAMAGE DUE TO ACTIVATED ELECTRODE OF A HIGH FREQUENCY THERAPEUTIC DEVICE.

    Additional Manufacturer Narrative · 1

    THE 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

    BEFORE THE PROCEDURE, THE FOLLOWING WAS FOUND. -THE DISTAL END COVER WAS CRACKED. -A PART OF THE DISTAL END 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
    56542 EVIS EXERAII BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-1T180

    Patients

    Seq Age Sex Outcome Treatment
    1