BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE REPROCESSOR

    MDR report key: 10200797 · Received June 26, 2020

    Report

    Report Number
    8010047-2020-03682
    Event Type
    Malfunction
    Date Received
    June 26, 2020
    Date of Event
    June 1, 2020
    Report Date
    August 29, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FEB
    UDI-DI
    04953170258589
    PMA / PMN Number
    K103264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT WAS SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FOR REPORT. THE ORIGINAL EQUIPMENT MANUFACTURER (OMSC) PERFORMED A DEVICE HISTORY RECORD REVIEW AND NO ABNORMALITIES WERE NOTED. AN INVESTIGATION WAS COMPLETED BY THE OMSC AND DETERMINED THAT THERE IS NO MANUFACTURING, MATERIAL OR PROCESSING RELATED CAUSE FOR THIS FAILURE MODE. THE CAUSE OF THE EVENT CANNOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED ON THE FIELD SERVICE ENGINEER'S ONSITE INSPECTION, THE DISINFECTANT DRAWER WAS STUCK DURING THE LOAD LCG PROCESS, AND THEN THE PROBLEM SOLVED BY RE-INSTALLING THE BOTTLE PROPERLY. WE COULD NOT CONFIRM ANY FACTOR FROM THE DESIGN NOR STRUCTURE OF THE DEVICE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE. THE USER MANUAL PROVIDES INFORMATION REGARDING NORMAL INSTALLMENT OF DISINFECTANT BOTTLES BY CONDUCTING THE METHOD STATES IN CHAPTER 7, ROUTINE MAINTENANCE, 7.12 REPLACING THE DISINFECTANT SOLUTION.

    Additional Manufacturer Narrative · 1

    THE TECHNICAL ASSISTANCE GROUP ASSISTED THE USER FACILITY WITH TROUBLESHOOTING AND ADVISED TO MAKE SURE THE BOTTLE WASN'T PLACED IN UPSIDE DOWN OR IT COULD POSSIBLY BE AN ISSUE WITH EXTRA LABELING CAUSING IT TO GET STUCK. THE USER PERFORMED ANOTHER DRAIN/LOAD LCG TO RELEASE THE DOOR AND ALLOWED THE LOAD LCG PROCESS TO CONTINUE. AFTER OPENING THE DRAWER THE USER NOTICED THE ACECIDE-C BOTTLES WERE PLACED IN AN UPSIDE DOWN POSITION. THE USER ADVISED THAT THE DISINFECTANT DRAWER WAS NOW ABLE TO BE CLOSED AND CONTINUE WITH THE LOAD LCG PROCESS WITHOUT FURTHER ISSUES. THE INVESTIGATION IS ONGOING, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    THE TECHNICAL ASSISTANCE GROUP WAS INFORMED BY THE USER FACILITY THAT THE ENDOSCOPE REPROCESSOR'S DISINFECTANT DRAWER WAS STUCK DURING THE LOAD LCG PROCESS AND WOULDN'T ALLOW THEM TO CLOSE THE DISINFECTANT DRAWER. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662557 ENDOSCOPE REPROCESSOR ENDOSCOPE REPROCESSOR FEB OLYMPUS MEDICAL SYSTEMS CORP. OER-PRO 04953170258589

    Patients

    Seq Age Sex Outcome Treatment
    1