BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 16456548 · Received February 28, 2023

    Report

    Report Number
    9610595-2023-03446
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    October 20, 2022
    Report Date
    March 31, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE HAS BEEN RETURNED TO AN OLYMPUS REPAIR CENTER FOR EVALUATION AND INSPECTION, AND THE CUSTOMER'S REPORTED E315 ERROR MESSAGE HAS NOT BEEN CONFIRMED. THE PRESENCE OF FOREIGN MATERIAL HAS BEEN CONFIRMED HOWEVER. IN ADDITION, A WATER LEAK IN THE SCOPE CONNECTOR HAS BEEN OBSERVED. THIS INVESTIGATION IS ONGOING. 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

    CORRECTED FIELD: (G3) ORIGINAL AWARE DATE IS 27DEC2022. 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. IT HAS BEEN OVER LESS THAN A YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE FOREIGN MATERIAL WAS CONFIRMED TO BE RUST AS A RESULT OF THE USER¿S REPROCESSING PROCESS. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. THIS ISSUE HAS BEEN ADDRESSED IN THE FOLLOWING MANNER: ·WE WOULD LIKE YOU TO MAINTAIN A PRE-USE CHECK AND PERIODIC CHECK. ·A SERVICE BULLETIN CALLS ATTENTION TO WHEN IMPLEMENT THE CLEANING / DISINFECTION OF THE SCOPE WITH THE HIGHLY ACID ELECTROLYSIS WATER UTILIZED FOR THE REPROCESSOR MANUFACTURED BY THE KAIGEN. THEREFORE, IT WOULD BE APPRECIATED IF YOU COULD ALSO CHECK FOR THE HANDLING SITUATION INCLUDING A USAGE, STORAGE, USAGE ENVIRONMENT AND THE METHODS. ·AS THE VERIFICATION IN CONJUNCTION WITH THE REPROCESSOR FROM OTHER MANUFACTURER WAS NOT IMPLEMENTED, IT WOULD BE APPRECIATED IF YOU COULD CHECK WITH THE CONTACT TO THE MANUFACTURER RELEVANT TO THE REPROCESSOR AS NEEDED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE END USER FACILITY CONTACTED OLYMPUS TO REPORT A REPAIR REQUEST FOR AN E315 ERROR MESSAGE WITH A EVIS EXERA LLL GASTROINTESTINAL VIDEOSCOPE. THE REPORTED PHENOMENON OCCURRED DURING PREPARATION FOR USE FOR A DIAGNOSTIC GASTROINTESTINAL ENDOSCOPY (GIE) PROCEDURE. THE PROCEDURE WAS CANCELLED. DURING EVALUATION AND INSPECTION OF THE RETURNED SUBJECT DEVICE, FOREIGN/STAINED MATERIAL WAS FOUND IN THE NOZZLE. THIS MDR IS BEING SUBMITTED DUE TO THE FOREIGN MATERIAL FOUND DURING EVALUATION AND INSPECTION. NO PATIENT OR USER HARM HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921106 EVIS EXERA LLL GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-H190N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CLV-190, SN (B)(6)| CV-190 PLUS, SN (B)(6)