BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OER-4 100V

    MDR report key: 11490773 · Received March 16, 2021

    Report

    Report Number
    8010047-2021-03755
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    February 18, 2021
    Report Date
    March 16, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT INVESTIGATE THE DEVICE, BECAUSE THE DEVICE WAS NOT RETURNED TO OMSC. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. THE EXACT CAUSE WAS UNKNOWN. BASED UPON THE INFORMATION FROM COMPLAINT, OMSC SURMISED THAT THE REPORTED PHENOMENON WAS OCCURRED DUE TO INSUFFICIENT HANDING OVER BY THE CHANGE OF FACILITY STAFF.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE LOCAL SERVICE ENGINEER THAT AFTER CHANGING THE PERSON IN CHARGE OF THE FACILITY, THE PERSON IN CHARGE OF THE FACILITY DOES NOT CHECK THE CONCENTRATION LEVEL OF THE DISINFECTANT SOLUTION EVERY TIME. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389844 OER-4 100V ENDOSCOPE REPROCESSOR FEB OLYMPUS MEDICAL SYSTEMS CORP. OER-4

    Patients

    Seq Age Sex Outcome Treatment
    1