BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE

    MDR report key: 14000591 · Received April 4, 2022

    Report

    Report Number
    8010047-2022-05632
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Report Date
    August 12, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GCJ
    UDI-DI
    04953170310355
    PMA / PMN Number
    K201832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED, THE REPORTED ISSUE WAS NOT CONFIRMED. THE BENDING SECTION COVER ADHESIVE WAS MISSING. THE ANGLE FIXING PART OF THE OPERATION PART WAS LOOSE. THERE WERE SCRATCHES ON THE OPERATION PART, GRIP, UP/DOWN/RIGHT/LEFT PLATES, SWITCH ONE (1), AND LIGHT GUIDE COVER GLASS DUE TO EXTERNAL FACTORS. THE LIGHT GUIDE CONNECTOR WAS DEFORMED DUE TO EXTERNAL FACTORS. THE VIDEO CONNECTOR, LIGHT GUIDE CONNECTOR, AND VIDEO CONNECTOR CASE MAY HAVE BEEN SCRATCHED DUE TO EXTERNAL FACTORS. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    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 THIS PROBLEM. A DEFINITIVE ROOT CAUSE FOR THIS ISSUE WAS NOT ESTABLISHED. HOWEVER, IT IS PROBABLE THAT THE ISSUE OCCURRED BECAUSE OF A SYSTEM FAILURE, A FAILURE WITH THE CDD UNIT, OR A FAILURE WITH THE INTERNAL BOARD OF THE ENDOSCOPE CONNECTOR. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE OLYMPUS REPRESENTATIVE, THE ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE PRESENTED A NOISY IMAGE AND SOMETIMES NO IMAGE. NO PATIENT HARM REPORTED. THIS REPORT IS TO CAPTURE THE REPORTABLE MALFUNCTION OF NO IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78094 ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE FLEX DEFLECTABLE VIDEOSCOPE GCJ OLYMPUS MEDICAL SYSTEMS CORP. LTF-S190-5 04953170310355

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown