BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OER-3 100V

    MDR report key: 11559097 · Received March 24, 2021

    Report

    Report Number
    8010047-2021-04096
    Event Type
    Malfunction
    Date Received
    March 24, 2021
    Date of Event
    February 26, 2021
    Report Date
    May 7, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC CONFIRMED THE DEVICE, AND FOUND THAT THE REPORTED PHENOMENON COULD NOT DUPLICATED AND THERE WAS NO ABNORMALITY OF 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 THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINED, BECAUSE OMSC COULD NOT CONFIRM THE PHENOMENON. THERE WAS THE POSSIBILITY THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE INSUFFICIENT PRECLEANING OF AN ENDOSCOPE BY THE USER.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC WILL START EVALUATING THE DEVICE. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT BROWN FOREIGN OBJECTS ADHERED TO THE OUTER SURFACE OF UNSPECIFIED COLONOSCOPES EVEN AFTER COMPLETION OF REPROCESSING STEPS BY THE DEVICE. THE USER THINKS THE BROWN OBJECTS TO BE A RESIDUE IN THE STOOL. 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
    457784 OER-3 100V ENDOSCOPE REPROCESSOR FEB OLYMPUS MEDICAL SYSTEMS CORP. OER-3

    Patients

    Seq Age Sex Outcome Treatment
    1