BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE REPROCESSOR

    MDR report key: 17954833 · Received October 18, 2023

    Report

    Report Number
    9610595-2023-15375
    Event Type
    Malfunction
    Date Received
    October 18, 2023
    Date of Event
    October 11, 2023
    Report Date
    January 17, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FEB
    UDI-DI
    04953170258589
    PMA / PMN Number
    K103264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE ENDOSCOPY ACCOUNT MANAGER (EAM) REPORTED THAT THE LIGHT HAD BEEN BLINKING INDICATING THAT THE ACECIDE-C NEEDED TO BE CHANGED. THE FACILITY REPORTED THAT THE MRC SAFETY CHECK WAS BEING PERFORMED AND IT WAS PASSING. THE FACILITY WAS ADVISED BY THE EAM THAT THEY ARE NOT TO USE ACECIDE-C PAST THE 5 DAY MARK EVEN IF IT WAS PASSING THE MRC CHECKS. THE FACILITY ADVICED THAT IT WAS A ONE TIME OCCURRENCE. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND CUSTOMER FOLLOW-UP. THE CUSTOMER CONFIRMED THE STAFF WAS AWARE OF INCIDENT AND WOULD HANDLE THE ISSUE INTERNALLY. THE SERIAL NUMBER WAS PROVIDED AND UPDATED IN D4. FURTHER REQUESTS FOR WHAT PROCEDURE/CASES THAT COULD HAVE USED SCOPES THAT WERE NOT REPROCESSED CORRECTLY WERE MADE BUT UNSUCCESSFUL. 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, A DEFINITIVE ROOT CAUSE OF THE REPORTED ENDOSCOPE BEING REPROCESSED IN AN OER-PRO REPROCESSOR WITHOUT REPLACING THE DISINFECTANT SOLUTION WITHIN THE DESIGNATED PERIOD OF TIME COULD NOT BE DETERMINED, HOWEVER, THE ISSUE WAS LIKELY THE RESULT OF THE USER NOT READING/FOLLOWING THE INSTRUCTION MANUAL CAREFULLY AND MADE A MISTAKE IN MANAGING THE REPLACEMENT OF DISINFECTANT. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATES: "OER-PRO OPERATION MANUAL 6.4 SETTING THE DISINFECTANT SOLUTION COUNTER ·NOTE ON THE DISINFECTANT SOLUTION COUNTER FUNCTION ACECIDE-C PRODUCT OVERVIEW ·REUSE PERIOD UP TO 5 DAYS CHAPTER 7 ROUTINE MAINTENANCE 7.12 REPLACING THE DISINFECTANT SOLUTION WHEN THE DISINFECTANT SOLUTION IN THE DEVICE IS NO LONGER EFFECTIVE, OR BEYOND THE SPECIFIED USE LIFE, DRAIN THE DISINFECTANT SOLUTION COMPLETELY AND REPLACE WITH FRESH DISINFECTANT SOLUTION. EXPIRED DISINFECTANT SOLUTION SHOULD BE TREATED AS DIRECTED IN THE DOCUMENTS SUPPLIED WITH THE DISINFECTANT SOLUTION. ACECIDE-C PRODUCT OVERVIEW PRODUCT DESCRIPTION ·REUSE PERIOD: UP TO 5 DAYS" OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE ENDOSCOPY ACCOUNT MANAGER (EAM) REPORTED TO OLYMPUS, THE ENDOSCOPE REPROCESSOR WAS USED WITH ACECIDE-C PAST THE FIVE DAY MARK. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242476 ENDOSCOPE REPROCESSOR ENDOSCOPE REPROCESSOR FEB AIZU OLYMPUS CO., LTD. OER-PRO 04953170258589

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown