BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE REPROCESSOR

    MDR report key: 11070927 · Received December 24, 2020

    Report

    Report Number
    8010047-2020-10957
    Event Type
    Malfunction
    Date Received
    December 24, 2020
    Date of Event
    December 1, 2020
    Report Date
    December 24, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), THEREFORE OMSC CANNOT INVESTIGATE THE DEVICE. 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 OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. OMSC SURMISED THAT THIS PHENOMENON ATTRIBUTED TO THE FOLLOWING. SOME OBJECT WAS DROPPED ON THE TOP COVER. THE USER PUSHED THE TOP COVER MORE THAN NECESSARY WHEN CLOSING THE TOP COVER. MECHANICAL STRESS WAS APPLIED WHEN CLOSING THE TOP COVER. CORROSION WAS CAUSED BY NOT WIPING OFF CHEMICAL SUBSTANCES (DETERGENTS, CHEMICALS, ETC.) ON THE TOP COVER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    DURING THE CLEANING AFTER ALL THE INSPECTIONS, THE USER FOUND THE LID OF THE DEVICE HAD BEEN CRACKED. THERE WAS NO WATER LEAKAGE FROM THE DEVICE. THERE WAS NO PATIENT INJURY REPORT RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536037 ENDOSCOPE REPROCESSOR ENDOSCOPE REPROCESSOR FEB OLYMPUS MEDICAL SYSTEMS CORP. OER-S

    Patients

    Seq Age Sex Outcome Treatment
    1