BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE

    MDR report key: 18143033 · Received November 15, 2023

    Report

    Report Number
    9610595-2023-17301
    Event Type
    Malfunction
    Date Received
    November 15, 2023
    Report Date
    December 15, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    GCJ
    UDI-DI
    04953170434648
    PMA / PMN Number
    K201832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S 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 IMAGE FREEZING WAS THE CONTROL SECTION REMOTE SWITCH, OR THE DEFECT OF THE CONTROL SECTION REMOTE SWITCH, AND THE INTERNAL CIRCUIT BOARD OF VIDEO CONNECTOR OR THE SYSTEM, OF WHICH COULD NOT BE NARROWED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: ¿¿CHAPTER 3 PREPARATION AND INSPECTION, 3.8 INSPECTION OF THE ENDOSCOPIC SYSTEM¿ DESCRIBES THE FOLLOWING WARNING. CONFIRM THAT THE WLI AND NBI ENDOSCOPIC IMAGES ARE NORMAL. DO NOT USE THE ENDOSCOPE IF THE ERROR MESSAGE OF THE FOG FREE FUNCTION IS DISPLAYED ON THE MONITOR. THE FOG FREE DEVICE MAY BE DAMAGED 1. BEFORE INSPECTION, WIPE THE OBJECTIVE LENS USING CLEAN LINT-FREE CLOTHS MOISTENED WITH SALINE SOLUTION OR STERILIZED WATER. 2. OBSERVE THE PALM OF YOUR HAND IN THE WLI AND NBI ENDOSCOPIC IMAGES. 3. CONFIRM THAT LIGHT IS OUTPUT FROM THE ENDOSCOPE¿S DISTAL END. (SEE FIGURE 3.23) 4. ADJUST THE BRIGHTNESS LEVEL AS APPROPRIATE. 5. CONFIRM THAT THE WLI AND NBI ENDOSCOPIC IMAGES ARE FREE FROM NOISE, BLUR, FOG, OR OTHER IRREGULARITIES. 6. TURN THE ANGULATION CONTROL LEVERS SLOWLY IN EACH DIRECTION UNTIL IT STOPS. 7. CONFIRM THAT THE WLI AND NBI ENDOSCOPIC IMAGES DO NOT MOMENTARILY DISAPPEAR OR DISPLAY ANY OTHER IRREGULARITIES. [WARNING] ALL REMOTE SWITCHES SHOULD BE CHECKED TO WORK NORMALLY EVEN IF THEY ARE NOT EXPECTED TO BE USED. THE ENDOSCOPIC IMAGES MAY FREEZE OR OTHER IRREGULARITIES MAY OCCUR DURING THE EXAMINATION AND MAY CAUSE PATIENT INJURY, BLEEDING AND/OR PERFORATION. [CAUTION] DEPRESS EVERY REMOTE SWITCH AND CONFIRM THAT THE SPECIFIED FUNCTIONS WORK NORMALLY.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    E1/ESTABLISHMENT NAME: (B)(6) THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS NOT CONFIRMED. THE DEVICE EVALUATION FOUND THE ADHESIVE ON THE BENDING SECTION COVER HAD A CHIP AND SWITCH 3 DID NOT WORK DUE TO DAMAGE. THE INVESTIGATION IS ONGOING AND FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE OLYMPUS FLEX DEFLECTABLE VIDEOSCOPE FREEZES OR RELEASES ON ITS OWN WHILE IN USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292230 ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE FLEX DEFLECTABLE VIDEOSCOPE GCJ AIZU OLYMPUS CO., LTD. LTF-S190-5 04953170434648

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown