BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE

    MDR report key: 12419343 · Received September 3, 2021

    Report

    Report Number
    8010047-2021-11195
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    August 3, 2021
    Report Date
    November 16, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS HONG KONG AND CHINA (OHC). OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THEREFORE, THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE INFORMATION FROM OHC AND SIMILAR PAST CASES, OMSC SURMISED THAT THIS PHENOMENON OCCURRED BECAUSE THE CABLE WAS DAMAGED AND THE IMAGE SIGNAL WAS NOT PROCESSED PROPERLY. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION BUT WAS RETURNED TO OLYMPUS (B)(4) AND (B)(4) (OHC). OHC CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED PHENOMENON WAS DUPLICATED DUE TO THE DAMAGE OF THE CCD UNIT/CABLE. THE EXACT CAUSE HAS BEEN UNDER INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF 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 FACILITY THAT DURING THE INSPECTION BEFORE THE USE, IT WAS FOUND THAT THE SCOPE COMMUNICATION ERROR E226 OCCURRED ON THE SUBJECT DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319604 ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE FLEX DEFLECTABLE VIDEOSCOPE GCJ OLYMPUS MEDICAL SYSTEMS CORP. LTF-S300-10-3D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown