BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 17444429 · Received August 2, 2023

    Report

    Report Number
    9610595-2023-11036
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Report Date
    August 2, 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. ESS PERFORMED REPROCESSING IN-SERVICE WITH THE STAFF THAT INCLUDED DEMONSTRATION. ESS RECOMMENDED THAT THE CUSTOMER FOLLOW ALL OLYMPUS REPROCESSING PROCEDURES AS DOCUMENTED IN THE REPROCESSING MANUAL, EXPLAINED THE IMPORTANCE OF EACH WHICH WAS ACKNOWLEDGED BY ALL STAFF IN ATTENDANCE. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICE WAS SHIPPED IN ACCORDANCE WITH SPECIFICATIONS. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. HOWEVER, 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 SUGGESTED EVENT IS PREVENTABLE BY HANDLING THE DEVICE IN ACCORDANCE WITH THE FOLLOWING INSTRUCTION FOR USE (IFU). PREVENTIVE MEASURES ARE INCLUDED IN GIF/CF/PCF-190 SERIES REPROCESSING MANUAL CHAPTER 5 REPROCESSING THE ENDOSCOPE AND 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 : PATIENT IDENTIFIER (B)(6), OER-PRO SN: (B)(6)- SCOPE REPROCESSOR. PATIENT IDENTIFIER (B)(6), (CF-HQ190L), SN: (B)(6), PATIENT IDENTIFIER (B)(6), (CF-HQ190L), SN: (B)(6), PATIENT IDENTIFIER (B)(6), (GIF-HQ190), SN: (B)(6), PATIENT IDENTIFIER (B)(6), (GIF-HQ190), SN: (B)(6), PATIENT IDENTIFIER (B)(6), (CF-HQ190L), SN: (B)(6), PATIENT IDENTIFIER (B)(6), (PCF-HQ190L) SN: (B)(6). THIS REPORT BEING SUBMITTED IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6), (GIF-HQ190), SN: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481450 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