BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 12923033 · Received December 3, 2021

    Report

    Report Number
    8010047-2021-15473
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    October 18, 2021
    Report Date
    January 12, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT RETURNED NOR HAS THE CUSTOMER PROVIDED ANY DETAILS, (INCLUDING MODEL NUMBER) FOR THE DEVICE. AS SUCH, AN ACTUAL DEVICE EVALUATION CANNOT BE PERFORMED. AN EVALUATION IS DONE BASED ON INFORMATION REPORTED BY CUSTOMER. THE DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED FOR THIS DEVICE AS CUSTOMER HAS NOT PROVIDED MODEL NUMBER OR SERIAL NUMBER FOR THE DEVICE. THE DEVICE REPROCESSED WITH EXPIRED DISINFECTANT WAS USED IN A PROCEDURE. THERE IS NO HARM TO THE PATIENT. THE EVENT IS INCORRECT REPROCESSING AND NOT ANY DEVICE MALFUNCTION, NOR AS REPORTED BY THE CUSTOMER WAS THERE AN ISSUE WITH THE DEVICE ONCE CORRECT REPROCESSING WAS PERFORMED. THE EVENT OCCURRED AS THE PERSON IN CHARGE OF REPLACING THE DISINFECTANT WAS UNAVAILABLE AND THE DISINFECTANT WAS NOT REPLACED. IT IS POSSIBLE THAT THE FACILITY STAFF WAS LESS TRAINED IN DEVICE HANDLING AND/OR REPROCESSING ACCORDING TO INSTRUCTIONS FOR USE (IFU). THE IFU INCLUDES THE FOLLOWING STATEMENTS (USING THE SCOPE CF-HQ190L AS REFERENCE, SINCE ACTUAL MODEL NUMBER OF THE SCOPE IS NOT AVAILABLE): ·IFU (REPROCESSING MANUAL) WARNS ON INSUFFICIENT REPROCESSING IN THE FOLLOWING. PRECAUTIONS: AN INSUFFICIENTLY CLEANED, DISINFECTED OR STERILIZED ENDOSCOPE AND/OR ACCESSORIES MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO CONTACT THEM. ·IFU STATES ON USE OF AUTOMATIC ENDOSCOPY REPROCESSOR (AER) AS FOLLOWS: FOLLOW THE WORKFLOW DESCRIBED IN SECTION 4.3, WORKFLOW FOR CLEANING AND DISINFECTING ENDOSCOPES AND ACCESSORIES USING AN AER/WD WHEN REPROCESSING ENDOSCOPES AND ACCESSORIES WITH AN AER/WD. ·IFU OF OER-PRO STATES THE FOLLOWING, THE EVENT IS SEEMINGLY PREVENTABLE BY SETTING COUNTER. 6.4 SETTING THE DISINFECTANT SOLUTION COUNTER ·NOTE ON THE DISINFECTANT SOLUTION COUNTER FUNCTION AN EXCERPT FROM OER-PRO OPERATION MANUAL: OLYMPUS RECOMMENDS USING ACECIDE TEST STRIPS FOR DETERMINING THE MRC OF ACECIDE-C. ACECIDE TEST STRIPS ARE MANUFACTURED BY BEST SANITIZERS, INC AND WERE CLEARED BY FDA VIA 510(K) K091210.)

    Additional Manufacturer Narrative · 0

    THERE ARE SEVEN MEDWATCHES ASSOCIATED WITH THIS EVENT. THE PATIENT IDENTIFIERS FOR THE MEDWATCHES ARE AS FOLLOWS:PATIENT IDENTIFIER (B)(6), OER-PRO AUTOMATED ENDOSCOPY REPROCESSOR (AER).PATIENT IDENTIFIER (B)(6), SCOPE 1, EVENT OCT 16, 2021, PROCEDURE 1.PATIENT IDENTIFIER (B)(6), SCOPE 2, EVENT OCT 16, 2021, PROCEDURE 2.PATIENT IDENTIFIER (B)(6), SCOPE 3, EVENT OCT 16, 2021, PROCEDURE 3.PATIENT IDENTIFIER (B)(6), SCOPE 1, EVENT OCT 18, 2021, PROCEDURE 4.PATIENT IDENTIFIER (B)(6), SCOPE 2, EVENT OCT 18, 2021, PROCEDURE 5.PATIENT IDENTIFIER (B)(6), SCOPE 3, EVENT OCT 18, 2021, PROCEDURE 6.THIS MEDWATCH IS FOR PATIENT IDENTIFIER (B)(6).DUE DILIGENCE HAS BEEN EXECUTED FOR THIS EVENT. CUSTOMER HAS NOT PROVIDED MORE DETAILS SUCH AS MODEL NUMBERS AND SERIAL NUMBERS ABOUT THE SCOPES REPROCESSED WITH EXPIRED DISINFECTANT AND USED IN PROCEDURES. THE FDA PRODUCT CODE AND COMMON DEVICE NAME ARE PLACEHOLDERS FOR THE PURPOSE OF MEDWATCH SUBMISSION.CUSTOMER WILL NOT PROVIDE PATIENT INFORMATION.THE DEVICE IS NOT BEING RETURNED AS THERE WAS NO DEVICE MALFUNCTION. AS SUCH, A DEFINITIVE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AT THIS TIME.SUPPLEMENTAL REPORT(S) WILL BE FILED AS THE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED FOR THIS EVENT BY THE CUSTOMER, THE DEVICE WAS REPROCESSED IN AN OLYMPUS AUTOMATED ENDOSCOPY REPROCESSOR (AER) OER-PRO WHICH HAD EXPIRED DISINFECTANT. THE DEVICE WAS THEN USED IN AN UNKNOWN PROCEDURE. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE PATIENT CONDITION IS FINE. THE PROCEDURE WAS COMPLETED IN A TIMELY MANNER WITH NO ISSUES. THERE WERE FIVE OTHER PROCEDURES WHERE THE SCOPES WERE REPROCESSED IN THE AER WITH THE EXPIRED DISINFECTANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819947 UNKNOWN SCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN
    1819974 UNKNOWN SCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OER-PRO, SN (B)(6)