BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 15510935 · Received September 30, 2022

    Report

    Report Number
    9610595-2022-02408
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Report Date
    June 28, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170305276
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY¿S MDR AND COMPLAINT HANDLING PROCESSES. CAPAS HAVE BEEN OPENED TO MANAGE THE ACTIONS THAT ARE BEING TAKEN TO REMEDIATE THIS ISSUE AND ENSURE ANY REQUIRED MDR REPORTING IS COMPLETED. 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, IT IS LIKELY THAT THE ENTIRE IMAGE WAS BLURRED DUE TO DAMAGE TO THE CHARGE COUPLED DEVICE (CCD) UNIT, THE ENTIRE IMAGE WAS BLURRED DUE TO SLIDING ERROR OF MOVABLE L-RANGE THAT OCCURRED IN THE ZOOM SCOPE, BLURRING OF THE ENTIRE IMAGE OCCURRED WITHIN THE ALLOWABLE RANGE, OR THE ENTIRE IMAGE WAS BLURRED DUE TO DAMAGE OR DEFORMATION OF THE CONNECTOR. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. THIS INFORMATION IS ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU): "·OPERATION MANUAL - INSPECTION OF THE ENDOSCOPIC SYSTEM ·OPERATION MANUAL IMPORTANT INFORMATION ¿ PLEASE READ BEFORE USE - WARNINGS AND CAUTIONS" OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE PRODUCT CODE FOR THE SUBJECT DEVICE FROM FDF TO FDS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THE DEVICE HAD ABNORMAL ELECTRICAL PROPERTIES. THE REPORTED PROBLEM WAS FOUND DURING DEMONSTRATION. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS RETURNED TO THE SERVICE CENTER WHERE EVALUATION DISCOVERED A BLURRY IMAGE. THIS REPORT IS BEING SUBMITTED FOR THE REPORTABLE MALFUNCTION FOUND AT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1952589 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE FLEXIBLE VIDEO GASTRODUODENOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ190 04953170305276
    486256 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE FLEXIBLE VIDEO GASTRODUODENOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ190 04953170305276

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown