BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 19226997 · Received May 1, 2024

    Report

    Report Number
    9610595-2024-09030
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Report Date
    May 30, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. ADDITIONAL INFORMATION ADDED TO FIELD H3 AND H6. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 5 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION AND THE INFORMATION PROVIDED, IT COULD NOT BE DETERMINED WHAT THE FOREIGN MATERIAL WAS. IT WAS UNKNOWN IF THERE WERE ANY DEVIATIONS FROM THE CLEANING DISINFECTION AND STERILIZATION (CDS) STEPS PROVIDED IN THE INSTRUCTIONS FOR USE (IFU). THEREFORE, THE CAUSE OF THE MATERIAL REMAINING IN THE DEVICE COULD NOT BE DETERMINED. THE INSTRUCTION MANUAL STATES THE DETECTION METHOD ASSOCIATED WITH THE EVENT IN "GIF/CF/PCF-190 SERIES, OPERATION MANUAL, CHAPTER 3 ¿PREPARATION AND INSPECTION", AND PREVENTATIVE MEASURES IN INSTRUCTIONS FOR GIF/CF/PCF-190 SERIES, REPROCESSING MANUAL, CHAPTER 5 ¿REPROCESSING OF THE ENDOSCOPE (AND RELATED REPROCESSING ACCESSORIES)". THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A FOREIGN MATTER COMING OUT OF THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857191 EVIS EXERA LLL GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-H190N

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown