BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II COLONOVIDEOSCOPE

    MDR report key: 10730259 · Received October 23, 2020

    Report

    Report Number
    8010047-2020-08086
    Event Type
    Malfunction
    Date Received
    October 23, 2020
    Date of Event
    October 1, 2020
    Report Date
    March 4, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170202445
    PMA / PMN Number
    K100584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE LEGAL MANUFACTURER INVESTIGATION. THE LEGAL MANUFACTURER (LM) REVIEWED THE CONTENT OF THIS COMPLAINT FOR FURTHER INVESTIGATION. THE LEGAL MANUFACTURER CONFIRMED THE SUBJECT SCOPE WAS SHIPPED IN ACCORDANCE WITH SPECIFICATIONS VIA DHR. THE LM REPORTED THAT THE MOST PROBABLE CAUSE FOR THE REPORTED EVENT IS AS FOLLOWS: IN THE USER FACILITY, REPROCESSING STAFF ISN'T PERFORMING ANY PRE-CLEANING STEPS AT BEDSIDE, NOT FLUSHING ENDOSCOPE CHANNELS WITH DETERGENT, WATER, AIR DURING MANUAL CLEANING, NOR FLUSHING ALCOHOL AFTER HLD. CDS PROCESS CONDUCTED IN THE USER FACILITY DEVIATED FROM CDS PROCESS RECOMMENDED BY IFU.

    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 TO ENSURE THEY LEARNED THE CORRECT PROCESS TO REPROCESS ENDOSCOPES. THE ESS INSPECTED THE 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 PRECLEANING 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 A CUSTOMER ONSITE IN-SERVICE WITH AN ENDOSCOPY SUPPORT SPECIALIST (ESS), IT WAS FOUND THE CUSTOMER WAS IMPROPERLY REPROCESSING THE SCOPE. THE ESS REPORTED THAT THE CUSTOMER WAS NOT PERFORMING PRECLEANING AT BEDSIDE, NOT FLUSHING THE ENDOSCOPE'S CHANNELS WITH DETERGENT, WATER, AIR, NOR FLUSHING ALCOHOL AFTER HIGH LEVEL DISINFECTION (HLD). THE CUSTOMER INFORMED THE ESS THAT THE FACILITY¿S REPROCESSING STAFF BEGAN TO REPROCESS ENDOSCOPES APPROXIMATELY A YEAR AGO AFTER THE GI DEPARTMENT WAS CLOSED AT THE FACILITY. THE STAFF DIDN'T RECEIVE REPROCESSING TRAINING AND WAS UNAWARE 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
    1188891 EVIS EXERA II COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H180AL 04953170202445

    Patients

    Seq Age Sex Outcome Treatment
    1