BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 17264828 · Received July 6, 2023

    Report

    Report Number
    9610595-2023-09743
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    June 6, 2023
    Report Date
    July 6, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170305276
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. ESS PROVIDED THE STAFF AN INSTRUCTIONS FOR USE (IFU) ON HOW TO CORRECTLY CLEAN THE SCOPE. REPROCESSING IN-SERVICE WAS PROVIDED. STAFF WERE INSTRUCTED ON HOW TO DRAIN THE OLD LIQUID CHEMICAL GERMICIDE (LCG) AND LOAD THE NEW LCG INTO THE OLYMPUS ENDOSCOPE REPROCESSOR (OER). STAFF PERFORMED A CHECK OF THE LCG PRIOR TO PROCEEDING, BY LOADING SCOPES IN THE OER. INSTRUCTED STAFF ON EFFICACY FOR ACECIDE-C. THE ESS EXPLAINED THE IMPORTANCE OF THE INFORMATION AND THE RECOMMENDATION PROVIDED AND WAS ACKNOWLEDGED BY THE STAFF IN ATTENDANCE. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICE WAS SHIPPED IN ACCORDANCE WITH SPECIFICATIONS. IT HAS BEEN LESS THAN ONE YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. IT WAS CONSIDERED THAT THE USER UNDERSTANDING DIFFERED FROM OLYMPUS RECOMMENDATION IN DEVICE HANDLING AND/OR REPROCESSING STEPS. OLYMPUS SPECIALIZED STAFF PROVIDED TRAINING IN THE CORRECT HANDLING. THE ISSUE IS ADDRESSED IN THE REPROCESSING MANUAL: CHAPTER 5 REPROCESSING THE ENDOSCOPE AND IN THE ENDOSCOPE REPROCESSOR OER-PRO INSTALLATION MANUAL. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING AN OER-PRO IN SERVICE, THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS), DISCOVERED THAT THE LIQUID CHEMICAL GERMICIDE (LCG) WAS NOT BEING TESTED BEFORE EACH CYCLE. ESS DETERMINED THAT THE LCG IN THE OER-PRO WAS EXPIRED. THERE IS NO PATIENT INFECTION ASSOCIATED ON THIS REPORTED EVENT. NO HARM WAS REPORTED AND THERE HAVE BEEN NO REPORTS OF PATIENT HARM AS A RESULT OF THESE EVENTS. THIS EVENT IS RELATED TO THE FOLLOWING PATIENT IDENTIFIERS BELOW : SCOPE REPROCESSOR AND SCOPES THAT WERE REPROCESSED IN THE SCOPE REPROCESSOR WITH EXPIRED DISINFECTANT CONCENTRATION : (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990954 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ190 04953170305276

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OER-PRO SN: (B)(6).SCOPE REPROCESSOR