BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 19076883 · Received April 9, 2024

    Report

    Report Number
    9610595-2024-07471
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Report Date
    April 22, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    PMA / PMN Number
    K011151
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. 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 12 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE LEGAL MANUFACTURE REVIEWED THE CLEANING DISINFECTION AND STERILIZATION (CDS) PROCESSES PROVIDED BY THE CUSTOMER, AND NO OBVIOUS DEVIATIONS FROM INSTRUCTIONS FOR USE (IFU) WERE IDENTIFIED. DURING EXAMINATION, THE FOREIGN MATERIAL COULD NOT BE IDENTIFIED. THERE WAS NO PHYSICAL DAMAGE WHERE THE FOREIGN MATERIAL WAS FOUND. BASED ON THE RESULTS OF THE INVESTIGATION, THE CAUSE OF FOREIGN MATERIAL THAT REMAINED IN THE NOZZLE WAS NOT CONFIRMED. THE INSTRUCTION MANUAL STATES THE DETECTION METHOD ASSOCIATED WITH THE EVENT IN "EVIS LUCERA GIF/CF/PCF TYPE 260 SERIES, OPERATION MANUAL, CHAPTER 3 PREPARATION AND INSPECTION", AND PREVENTATIVE MEASURES IN "EVIS LUCERA GIF/CF/PCF/SIF TYPE 260 SERIES, REPROCESSING MANUAL, CHAPTER 3 CLEANING, DISINFECTION, AND STERILIZATION PROCEDURES". OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE HAD A FOREIGN OBJECT COME OUT OF THE NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428333 EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-H260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown