BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE REPROCESSOR

    MDR report key: 12188143 · Received July 19, 2021

    Report

    Report Number
    8010047-2021-09052
    Event Type
    Malfunction
    Date Received
    July 19, 2021
    Date of Event
    June 24, 2021
    Report Date
    October 7, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FEB
    UDI-DI
    04953170258589
    PMA / PMN Number
    K103264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION. AS SUCH, AN ACTUAL DEVICE EVALUATION IS NOT PERFORMED. AN EVALUATION IS DONE BASED ON HISTORICAL RECORDS. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. DUE DILIGENCE WAS EXECUTED FOR THIS EVENT WITH NO RESPONSE, INCLUDING INITIAL REPORTER OCCUPATION, BY THE CUSTOMER. THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT DEVICE CONFORMED TO SPECIFICATIONS AT THE TIME OF SHIPPING. THERE IS NO AVAILABLE REPAIR HISTORY FOR THIS DEVICE. IN TROUBLESHOOTING, THE USER WAS INFORMED THAT BLINKING OF THE LCG LIGHTS CAN OCCUR IF THE ¿DRAIN LCG¿ CYCLE IS INTERRUPTED EITHER BY AN ERROR WHILE DRAINING OR IT WAS STOPPED BY THE USER. THE CUSTOMER HAD STATED THAT THE DRAIN LCG WAS INTERRUPTED. CUSTOMER WAS GOING COMPLETE THE DRAIN LCG CYCLE TO SEE IF THE ISSUE WAS ELIMINATED. CUSTOMER DID NOT CALL BACK TO REPORT THAT THE ISSUE PERSISTED, NOR DID THE CUSTOMER RESPOND TO DUE DILIGENCE ATTEMPTS. THEREFORE IT IS INFERRED THAT THE DISINFECTANT REPLACEMENT INDICATOR, WAS NOT RESET BECAUSE DRAIN LCG CYCLE WAS INTERRUPTED. THE EVENT WAS NOT CAUSED DUE TO MALFUNCTION OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED TECHNICAL ASSISTANCE CENTER (TAC) WHEN THE ISSUE OF LCG LIGHTS BLINKING EVEN AFTER THE DISINFECTANT WAS CHANGED WAS OBSERVED. TAC SPECIALIST INFORMED THE CUSTOMER THIS ISSUE CAN OCCUR IF THE DRAIN LCG (DRAINING OF THE DISINFECTANT SOLUTION FROM THE DISINFECTANT SOLUTION TANK) CYCLE IS INTERRUPTED EITHER BY AN ERROR WHILE DRAINING OR IF STOPPED BY THE USER. THE LCG COUNTER WILL ONLY RESET AFTER THE DRAIN LCG CYCLE IS COMPLETED. THE CUSTOMER STATED THAT THE DRAIN LCG WAS INTERRUPTED. CUSTOMER WAS GOING COMPLETE THE DRAIN LCG CYCLE TO SEE IF THE ISSUE WAS ELIMINATED. ADDITIONAL INFORMATION IS NOT YET AVAILABLE FROM THE CUSTOMER. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED WHEN ANY RELEVANT NEW INFORMATION IS AVAILABLE. NOT AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    CORRECTION BEING MADE FOR INITIAL REPORTER EMAIL. THE EMAIL WAS INADVERTENTLY ADDED AND DOES NOT BELONG TO THE INITIAL REPORTER. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION.

    Description of Event or Problem · 1

    AS REPORTED BY THE CUSTOMER, THE DEVICE LCG LIGHTS WERE BLINKING EVEN AFTER THE DISINFECTANT WAS CHANGED. THERE IS NO REPORTED HARM TO ANY PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084531 ENDOSCOPE REPROCESSOR ENDOSCOPE REPROCESSOR FEB OLYMPUS MEDICAL SYSTEMS CORP. OER-PRO 04953170258589

    Patients

    Seq Age Sex Outcome Treatment
    1