BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OER-4 100V

    MDR report key: 12298905 · Received August 10, 2021

    Report

    Report Number
    8010047-2021-10004
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Report Date
    October 6, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REPORT THE WITHDRAWAL OF MFR REPORT #8010047-2021-10004 AND CORRECT THE INITIAL REPORT. OLYMPUS RE-EVALUATED THE EVENT REPORTED IN THE INITIAL REPORT AND DETERMINED THAT THE FAILURE MODE IS NOT A MDR REPORTABLE MALFUNCTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ANY OF OLYMPUS LOCATIONS. THEREFORE, OLYMPUS COULD NOT INVESTIGATE THE DEVICE. THE USER ALSO REPORTED THAT THE FRONT PANEL SWITCH WAS UNRESPONSIVE. THE PERSON IN CHARGE OF MVC CO., LTD. VISITED THE USER FACILITY AND REPAIRED IT ON SITE. THE DAMAGED PART WAS DISCARDED BY MVC CO., LTD.. 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

    DURING PREPARATION, THE USER FACILITY FOUND THAT THE LID OF THE DEVICE WAS CRACKED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202055 OER-4 100V ENDOSCOPE REPROCESSOR FEB OLYMPUS MEDICAL SYSTEMS CORP. OER-4

    Patients

    Seq Age Sex Outcome Treatment
    1