BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE REPROCESSOR

    MDR report key: 13383815 · Received January 28, 2022

    Report

    Report Number
    8010047-2022-02120
    Event Type
    Malfunction
    Date Received
    January 28, 2022
    Date of Event
    December 29, 2021
    Report Date
    March 1, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FEB
    UDI-DI
    04953170258589
    PMA / PMN Number
    K103264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FIELD SERVICE ENGINEER (FSE) WENT ON SITE OF THE FACILITY TO EVALUATE A REPORTED ISSUE OF THE DISINFECTANT BOTTLE DRAWER OF THE DEVICE NOT OPENING WHEN THE LOAD LCG FUNCTION BEGAN AUTOMATICALLY UPON COMPLETION OF THE DRAIN LCG FUNCTION. FSE WENT ON SITE AND FOUND THE DEVICE WAS ON WITH INDICATOR SPINNING IN THE LOAD PHASE WITH THE DRAWER WAS NOT PUSHED IN ALL THE WAY. THE DISINFECTANT PREPARATION PROCESS COULD NOT BE COMPLETED. FSE PUSHED THE DRAWER ALL THE WAY IN, THIS MADE THE LOAD FUNCTION FAIL AND CONFIRMED THAT THE DEVICE SENSORS WERE WORKING. FSE THEN PERFORMED THE DRAIN LCG CYCLE AGAIN, TO MAKE SURE ALL THE FLUID WAS OUT OF THE DEVICE. FSE WAS ABLE TO OPEN THE DRAWER AND LOAD THE DISINFECTANT. FSE RAN A CYCLE WITH NO ISSUES. THERE WAS NO DEVICE MALFUNCTION AND NO REPAIR REQUIRED. FSE ONLY ALLOWED LOAD CYCLE TO COMPLETE BEFORE PERFORMING DUMP AND RE-LOAD OF THE DISINFECTANT. DEVICE PANELS WERE NOT REMOVED. EQUIPMENT WAS VERIFIED ACCORDING TO ORIGINAL EQUIPMENT MANUFACTURERS INSTRUCTIONS. SOFTWARE ATTRIBUTES HAVE BEEN VERIFIED AND CONFIRMED. THE COVERS OF THE OER-PRO WERE NOT REMOVED SO AN ELECTRICAL SAFETY CHECK WAS NOT REQUIRED EVALUATION IS ONGOING. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED WHEN ANY RELEVANT NEW INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY WHEN THE USER SET THE DISINFECTANT BOTTLE, THE DISINFECTANT BOTTLE TRAY MAY HAVE BEEN LOCKED WITHOUT INSERTING THE TRAY COMPLETELY. THE TRAY REMAINED IN THAT STATE, CAUSING THE SUGGESTED EVENT. THIS EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATES: "7.12 REPLACING THE DISINFECTANT SOLUTION: 11. LIFT THE DISINFECTANT BOTTLE DRAWER SO THAT IT IS LEVEL, AND INSERT IT ALL THE WAY. THE BUZZER SHOULD BEEP, THE DRAWER SHOULD LOCK, AND THE DISINFECTANT CASSETTE BOTTLES SHOULD OPEN AUTOMATICALLY." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    FIELD SERVICE ENGINEER (FSE) WENT ON SITE OF THE FACILITY TO EVALUATE A REPORTED ISSUE OF THE DISINFECTANT BOTTLE DRAWER OF THE DEVICE NOT OPENING WHEN THE LOAD LCG FUNCTION BEGAN AUTOMATICALLY UPON COMPLETION OF THE DRAIN LCG FUNCTION. THE BUTTONS OF THE DEVICE WERE UNRESPONSIVE. FSE WENT ON SITE AND FOUND THE DEVICE WAS ON WITH INDICATOR SPINNING IN THE LOAD PHASE WITH THE DRAWER WAS NOT PUSHED IN ALL THE WAY. THE DISINFECTANT PREPARATION PROCESS COULD NOT BE COMPLETED. FSE PUSHED THE DRAWER ALL THE WAY IN, THIS MADE THE LOAD FUNCTION FAIL AND CONFIRMED THAT THE DEVICE SENSORS WERE WORKING. FSE THEN PERFORMED THE DRAIN LCG CYCLE AGAIN, TO MAKE SURE ALL THE FLUID WAS OUT OF THE DEVICE. FSE WAS ABLE TO OPEN THE DRAWER AND LOAD THE DISINFECTANT. THERE IS NO PATIENT INVOLVEMENT FOR THIS EVENT. THIS MEDWATCH IS BEING SUBMITTED FOR THE ISSUE OF THE DISINFECTANT PREPARATION PROCESS NOT BEING COMPLETED AS OBSERVED BY THE FSE ON SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55753 ENDOSCOPE REPROCESSOR ENDOSCOPE REPROCESSOR FEB OLYMPUS MEDICAL SYSTEMS CORP. OER-PRO 04953170258589

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown