BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 19297534 · Received May 13, 2024

    Report

    Report Number
    9610595-2024-09591
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    May 3, 2024
    Report Date
    May 30, 2024
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF 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. IT HAS BEEN OVER 7 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION AND THE INFORMATION PROVIDED, THE FOREIGN MATERIAL COULD NOT BE IDENTIFIED. IT IS UNCLEAR WHETHER REPROCESSING WAS PERFORMED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). CONSEQUENTLY, THE CAUSE OF THE MATERIAL REMAINING IN THE DEVICE COULD NOT BE DETERMINED. HOWEVER, THE FOREIGN MATERIAL MAY NOT HAVE BEEN REMOVED BECAUSE PROPER REPROCESSING MIGHT HAVE BEEN HINDERED BY LEAKAGE IN THE BIOPSY CHANNEL. THE SUGGESTED EVENT IS DETECTABLE/PREVENTABLE BY HANDLING THE DEVICE IN ACCORDANCE WITH THE FOLLOWING IFU. ¿IFU STATES THE DETECTION METHOD IN GIF/CF/PCF-190 SERIES OPERATION MANUAL CHAPTER 3 PREPARATION AND INSPECTION. IFU STATES THE PREVENTATIVE MEASURES IN GIF/CF/PCF-190 SERIES REPROCESSING MANUAL CHAPTER 5 REPROCESSING THE ENDOSCOPE.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A CLOGGED NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843179 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ190 04953170305276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown