BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODENOVIDEOSCOPE

    MDR report key: 10776723 · Received November 3, 2020

    Report

    Report Number
    8010047-2020-08453
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    September 29, 2020
    Report Date
    December 11, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170307553
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION, BUT WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS INDIA (OMSI). OMSI CONFIRMED THE REPORTED PHENOMENON. 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, SINCE AIR LEAK WAS CONFIRMED IN THE INSTRUMENT CHANNEL OF THE SUBJECT DEVICE, IT IS PRESUMED THAT THE REPORTED PHENOMENON OCCURRED DUE TO THE INTRUSION OF MOISTURE AND FOREIGN OBJECT INTO THE DEVICE FROM THE AIR LEAK LOCATION.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO 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

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT IT WAS FOUND THAT THERE WAS DIRT INSIDE THE LIGHT GUIDE LENS OF THE SUBJECT DEVICE DURING THE INCOMING INSPECTION OF THE SUBJECT DEVICE FOR THE REPAIR AT OLYMPUS MEDICAL SYSTEMS INDIA PRIVATE LIMITED (OMSI).THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246773 DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-150 04953170307553

    Patients

    Seq Age Sex Outcome Treatment
    1