BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 10729928 · Received October 23, 2020

    Report

    Report Number
    8010047-2020-08082
    Event Type
    Malfunction
    Date Received
    October 23, 2020
    Date of Event
    October 1, 2020
    Report Date
    January 12, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    UDI-DI
    04953170339776
    PMA / PMN Number
    K100584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LEGAL MANUFACTURER (LM) REVIEWED THE CONTENT OF THIS COMPLAINT FOR FURTHER INVESTIGATION. AS THE RESULT OF DHR REVIEW, IT WAS CONFIRMED THAT THE SUBJECT DEVICE WAS SHIPPED FROM THE FACTORY IN ACCORDANCE WITH SPECIFICATIONS. NO ROOT CAUSE ANALYSIS WAS PERFORMED SINCE THERE WAS NO DEVICE MALFUNCTION. ACCORDING TO THE DEVICE FAILURE REPORT, IT WAS CONFIRMED THAT THE SUBJECT DEVICE WAS NOT REPAIRED IN THE PAST ONE YEAR. THE LEGAL MANUFACTURER REPORTED THAT IN THE IFU, THERE IS WARNING OF THE POSSIBILITY ABOUT INFECTION CAUSED BY IMPROPER REPROCESSING IS DESCRIBED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. AS PART OF THE INVESTIGATION, THE ESS PERFORMED AN IN-SERVICE THAT INCLUDED LEAK TESTING, MANUAL CLEANING, DISINFECTION, AND STERILIZATION INFORMATION FROM THE REPROCESSING MANUAL. THE ESS DEMONSTRATED HOW TO MANUALLY FLUSH ENDOSCOPES USING INJECTION TUBE MH-946, SUCTION TUBING ADAPTER MH-856, CHANNEL PLUG ADAPTER MH-944 AND AUXILIARY WATER TUBE MAJ-855. STAFF WAS ALSO TRAINED ON HOW TO REPROCESS ACCESSORIES AFTER EACH USE AND HOW TO FLUSH ALCOHOL AFTER HLD USING CDS ACCESSORIES. EACH EMPLOYEE PERFORMED A RETURN-DEMONSTRATION TRAINING TO ENSURE THEY LEARNED THE CORRECT PROCESS TO REPROCESS ENDOSCOPES. THE ESS INSPECTED WATER RESISTANT CAP WHILE ON SITE. THE ESS RECOMMENDED THAT THE CUSTOMER PURCHASE CLEANING BRUSHES, REVIEW REPROCESSING VIDEOS ON THE MANUFACTURER¿S CONNECT WEBSITE AND SCHEDULE A FOLLOW-UP TRAINING WITH ESS ONCE ADDITIONAL CLEANING ITEMS ARE PURCHASED TO ENSURE THE SCOPES ARE BEING REPROCESSED IN ACCORDANCE WITH THE MANUFACTURER¿S RECOMMENDATIONS. IN ADDITION, THE ESS REPORTED THAT THE CUSTOMER WAS PROVIDED THE FOLLOWING DOCUMENTATION: INFECTION CONTROL STANDARDS QRG, COPY OF PRECLEARING GUIDE AND PROVIDED AN ENDOSCOPE CLEANING WALL CHART. THE CUSTOMER WAS ALSO PROVIDED INFORMATION REGARDING THE OER-PRO AUTOMATIC ENDOSCOPE REPROCESSOR.

    Description of Event or Problem · 1

    THE SERVICE CENTER WAS INFORMED THAT DURING AN ONSITE CUSTOMER IN-SERVICE WITH AN ENDOSCOPY SUPPORT SPECIALIST (ESS), THE CUSTOMER WAS IMPROPERLY REPROCESSING THE SCOPE. THE ESS REPORTED THAT THE CUSTOMER WAS NOT PERFORMING PRECLEARING AT THE BEDSIDE, NOT FLUSHING THE ENDOSCOPE'S CHANNELS WITH DETERGENT, WATER, AIR, NOR FLUSHING ALCOHOL AFTER HIGH LEVEL DISINFECTION. THE CUSTOMER INFORMED THE ESS THAT THE FACILITY¿S REPROCESSING STAFF BEGAN TO REPROCESS ENDOSCOPES APPROXIMATELY A YEAR AGO AFTER GI DEPARTMENT WAS CLOSED AT THE FACILITY. THE STAFF DIDN'T RECEIVE REPROCESSING TRAINING AND WAS UNWARE OF THE CORRECT WAY TO REPROCESS ENDOSCOPES. THERE WAS NO PATIENT INVOLVEMENT OR DEVICE POSITIVE CULTURES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190420 EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-H180 04953170339776

    Patients

    Seq Age Sex Outcome Treatment
    1