BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE

    MDR report key: 11070941 · Received December 24, 2020

    Report

    Report Number
    8010047-2020-10959
    Event Type
    Malfunction
    Date Received
    December 24, 2020
    Report Date
    December 24, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K111425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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. SINCE THE DEVICE WAS NOT RETURNED, THE EXACT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED, BUT THERE WAS A POSSIBILITY OF FAILURE OF CCD AND CIRCUIT BOARD.

    Description of Event or Problem · 1

    OLYMPUS SERVICE OPERATION REPAIR CENTER WAS INFORMED FROM THE FACILITY THAT IN UNSPECIFIED TIMING, SNOW NOISE APPEARED ON THE MONITOR. OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS AND FOUND THAT A SCOPE COMMUNICATION ERROR B30 AND A SCOPE COMMUNICATION ERROR E226 APPEARED ON THE MONITOR. 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
    1536188 ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE FLEX DEFLECTABLE VIDEOSCOPE GCJ OLYMPUS MEDICAL SYSTEMS CORP. LTF-S190-10

    Patients

    Seq Age Sex Outcome Treatment
    1