BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE

    MDR report key: 15765332 · Received November 9, 2022

    Report

    Report Number
    9610595-2022-03752
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Report Date
    November 9, 2022
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    GCJ
    UDI-DI
    04953170310386
    PMA / PMN Number
    K111425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND EVALUATED BY OLYMPUS. IN ADDITION TO THE FINDINGS IN DESCRIBE EVENT OR PROBLEM, EVALUATION FOUND WATER TIGHTNESS WAS NOT MAINTAINED DUE TO THE OBJECTIVE LENS, THE BENDING ANGLE WAS INSUFFICIENT DUE TO ELONGATION OF THE ANGLE WIRE, THE CURVED RUBBER ADHESIVE WAS MISSING, THE OPERATING PART ANGLE FIXING PART WAS LOOSE, THE UNIVERSAL CORD WAS CUT, AND MULTIPLE PARTS OF SCOPE WERE SCRATCHED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. ALTHOUGH IT WAS DETERMINED THAT THE DEFECT WAS LIKELY CAUSED BY STRESS OF REPEATED USE, EXTERNAL FACTORS, OR HANDLING, A DEFINITIVE ROOT CAUSE OF THE OBJECTIVE LENS COMING OFF COULD NOT BE IDENTIFIED. A REVIEW OF LABELING FOUND THERE WAS NO INDICATION THE EVENT WAS CAUSED BY A MISUSE. REPAIR HISTORY WAS REVIEWED AND THERE WERE NO REPAIRS WITHIN THE PAST YEAR. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER DATE, THIS REPORT WILL BE SUPPLEMENTED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE CURVED RUBBER OF THE ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE WAS SCRATCHED. THE ISSUE WAS FOUND DURING INSPECTION. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE ADHESIVE PART OF THE OBJECTIVE LENS CAME OFF. THE REPORT IS BEING SUBMITTED DUE TO ADHESIVE OF THE LENS COMING OFF THAT WAS FOUND DURING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2950132 ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE FLEX DEFLECTABLE VIDEOSCOPE GCJ AIZU OLYMPUS CO., LTD. LTF-S190-10 04953170310386

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown