BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE

    MDR report key: 12082264 · Received June 29, 2021

    Report

    Report Number
    8010047-2021-08112
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Report Date
    May 3, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    GCJ
    UDI-DI
    04953170310355
    PMA / PMN Number
    K080948
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D5 - HEALTH PROFESSIONAL SHOULD HAVE BEEN SELECTED ON THE INITIAL REPORT. CORRECTION: H4 - DEC 4, 2017 SHOULD HAVE BEEN SELECTED ON THE INITIAL REPORT. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE EVENT WAS UNABLE TO BE IDENTIFIED; HOWEVER, THE EVENT MOST LIKELY OCCURRED DUE TO A MALFUNCTION OF THE IMAGE SENSOR UNIT, A BOARD INSIDE THE VIDEO CONNECTOR, OR A MALFUNCTION ON THE SYSTEM SIDE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS 9610595.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), BUT RETURNED TO OLYMPUS REPAIR CENTER FOR EVALUATION. OLYMPUS REPAIR CENTER COULD NOT CONFIRM "ERROR 227". DETAILS OF THE "ERROR 227" WERE UNKNOWN. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE USER COMMENTED THAT "ERROR 227" OCCURRED AND THE ENDOSCOPIC IMAGE WAS NOT DISPLAYED. THE USER RETURNED THE DEVICE TO OLYMPUS REPAIR CENTER. OLYMPUS REPAIR CENTER FOUND THAT ERROR B31 (SCOPE COMMUNICATION ERROR) WAS DISPLAYED. 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
    984421 ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE FLEX DEFLECTABLE VIDEOSCOPE GCJ AIZU OLYMPUS CO., LTD. LTF-S190-5 04953170310355

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown