BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 11144028 · Received January 9, 2021

    Report

    Report Number
    8010047-2021-01147
    Event Type
    Malfunction
    Date Received
    January 9, 2021
    Report Date
    February 17, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 PHENOMENON. OEKG FOUND CHIPS OF THE LIGHT GUIDE LENS AND ADHESIVE OF THE BENDING RUBBER. 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 TO THE DISTAL PART OF THE SUBJECT DEVICE DUE TO DEVICE HANDLING OF THE USER.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE 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 IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING THE REPROCESS PRIOR TO USE IT WAS FOUND THAT THE SUBJECT DEVICE HAD BEEN BROKEN. DURING THE INCOMING INSPECTION FOR REPAIR AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(4), IT WAS FOUND THAT THE DISTAL END COVER OF THE SUBJECT DEVICE WAS CRACKED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40256 EVIS EXERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-145

    Patients

    Seq Age Sex Outcome Treatment
    1