BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE

    MDR report key: 17574260 · Received August 18, 2023

    Report

    Report Number
    9610595-2023-11901
    Event Type
    Malfunction
    Date Received
    August 18, 2023
    Report Date
    October 3, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    HET
    UDI-DI
    04953170434938
    PMA / PMN Number
    K123365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION AND THE INVESTIGATION IS IN PROCESS. THE SUBJECT DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING ADDITIONAL ISSUES WERE IDENTIFIED: INSERTION TUBE CURVED RUBBER IS SCRATCHED AND THE RUBBER BOND IS CHIPPED, AND THE MASTER SIDE VIDEO CONNECTOR IS DEFORMED WITH SCRATCHES ON THE SLAVE SIDE. D2: ADDITIONAL CODES - FGB, GCJ, NWB. 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.

    Additional Manufacturer Narrative · 0

    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 SUGGESTED EVENT COULD NOT BE CONCLUDED, ALTHOUGH IT CAN BE PRESUMED THAT THE DEFECT WAS CAUSED BY STRESS OF REPEATED USE, EXTERNAL FACTORS, OR HANDLING OF THE DEVICE OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THERE WAS AN AIR LEAK WITH THE CABLE. THE SUBJECT DEVICE WAS WAS RETURNED FOR REPAIR. DURING DEVICE EVALUATION, IT WAS IDENTIFIED THE ADHESIVE AROUND THE OBJECTIVE LENS WAS PEELED. THIS IS A REPORTABLE MALFUNCTION. THERE IS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2333436 ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE FLEX 3D DEFLECTABLE VIDEOSCOPE HET AIZU OLYMPUS CO., LTD. LTF-190-10-3D 04953170434938

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown