BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE

    MDR report key: 12922991 · Received December 3, 2021

    Report

    Report Number
    8010047-2021-15477
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Report Date
    February 21, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K111425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS SERVICE OPERATION REPAIR CENTER (SORC). SORC CHECKED THE SUBJECT DEVICE AND FOUND THAT THE ENDOSCOPIC IMAGE OF THE SUBJECT DEVICE ON THE MONITOR HAD ABNORMAL COLOR TONE (THE IMAGE BECAME PINK) FOR FIVE TO TEN MINUTES, AND ALSO FOUND THAT THIS PHENOMENON WAS CAUSED BY THE CCD FAILURE. 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.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS TRANSFERRED FROM OLYMPUS SERVICE OPERATION REPAIR CENTER (SORC) TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED PHENOMENON WAS NOT DUPLICATED, AND ALSO FOUND THAT THERE WAS NO ABNORMALITY IN THE ARRANGEMENT OF THE INTERNAL COMPONENTS IN THE CAMERA CABLE. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE IDENTIFIED. HOWEVER, BASED UPON THE INVESTIGATION RESULT, OMSC SURMISED THAT THE REPORTED PHENOMENON MIGHT HAVE BEEN CAUSED BY AN ELECTRICAL SHORT CIRCUIT INSIDE THE CCD CIRCUIT BOARD/CABLE, OR A TEMPORARY CONTACT FAILURE DUE TO A FOREIGN MATERIAL CAUGHT BETWEEN THE ELECTRICAL CONTACTS OF THE VIDEO CONNECTOR AND THE ELECTRICAL CONTACTS OF THE VIDEO SYSTEM CENTER, SINCE THERE WAS NO KINK ETC. OF THE CABLE. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING THE UNSPECIFIED TIMING, IT WAS FOUND THAT THE ENDOSCOPIC IMAGE OF THE SUBJECT DEVICE ON THE MONITOR HAD ABNORMAL COLOR TONE (GREEN HALATION APPEARED) FIVE TO TEN MINUTES AFTER WHITE BALANCE ADJUSTMENT. THE OCCURRENCE DATE OF THE EVENT IS UNKNOWN, AND THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826335 ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE FLEX DEFLECTABLE VIDEOSCOPE GCJ OLYMPUS MEDICAL SYSTEMS CORP. LTF-S190-10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown