BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE

    MDR report key: 11926835 · Received June 3, 2021

    Report

    Report Number
    8010047-2021-07025
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    May 11, 2021
    Report Date
    June 25, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K111425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) INVESTIGATED THE DEVICE. HOWEVER, OMSC COULD NOT REPRODUCE THE REPORTED PHENOMENON. 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 FAILURE OF THE INTERNAL ELECTRIC CIRCUIT MOUNTED ON THE IMAGE SENSOR UNIT. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS REPAIR CENTER, BUT NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). THEREFORE, OMSC COULD NOT CONFIRM THE DEVICE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. OMSC SURMISED THAT THIS PHENOMENON ATTRIBUTED TO THE FAILURE OF THE IMAGE SENSOR UNIT, THE CIRCUIT BOARD INSIDE THE VIDEO CONNECTOR, OR THE VIDEO SYSTEM CENTER. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    DURING THE PREPARATION FOR USE BEFORE THE LAPAROSCOPIC PROCEDURE, THE USER FOUND THAT THE ENDOSCOPIC IMAGE DISAPPEARED AND THE NOISE WAS DISPLAYED AFTER 1 TO 2 SECONDS WHEN THE DEVICE POWER WAS TURNED ON. THE IMAGE ON THE MONITOR BECAME A GREEN OR WHITE IMAGE WHILE THIS EVENT OCCURRED. THE USER REBOOTED THE DEVICE, HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE USER REPLACED THE DEVICE WITH ANOTHER DEVICE AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831003 ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE FLEX DEFLECTABLE VIDEOSCOPE GCJ OLYMPUS MEDICAL SYSTEMS CORP. LTF-S190-10

    Patients

    Seq Age Sex Outcome Treatment
    1