BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 12888456 · Received November 29, 2021

    Report

    Report Number
    8010047-2021-15215
    Event Type
    Malfunction
    Date Received
    November 29, 2021
    Report Date
    December 17, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SORC CHECKED THE SUBJECT DEVICE AND FOUND THE PHENOMENON. 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.

    Additional Manufacturer Narrative · 0

    SORC CHECKED THE SUBJECT DEVICE AND FOUND THE PHENOMENON. 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.

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) CHECKED THE SUBJECT DEVICE AND CONFIRMED THE PHENOMENON. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. OMSC PRESUMED THAT THE PHENOMENON OCCURRED DUE TO INSIFFICIENT CLEANING.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT OLYMPUS SERVICE OPERATION REPAIR CENTER (SORC) ON NOVEMBER 5, 2021, IT WAS FOUND THAT THERE WAS DIRT ON THE OBJECTIVE LENS WHICH WAS DIFFICULT TO REMOVE.THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT OLYMPUS SERVICE OPERATION REPAIR CENTER (SORC) ON NOVEMBER 5, 2021, IT WAS FOUND THAT THERE WAS DIRT ON THE OBJECTIVE LENS WHICH WAS DIFFICULT TO REMOVE.THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1778359 GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-1200N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown