BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE REPROCESSOR

    MDR report key: 12591751 · Received October 7, 2021

    Report

    Report Number
    8010047-2021-12861
    Event Type
    Malfunction
    Date Received
    October 7, 2021
    Date of Event
    September 1, 2021
    Report Date
    November 1, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FEB
    UDI-DI
    04953170404047
    PMA / PMN Number
    K201920
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORTER CALLED INTO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC) PERSONNEL TO REPORT THEIR ISSUE. THE CUSTOMER ADVISED THAT THEY PERFORM A LOAD LIQUID CIRCULATING GARMENT (LCG) ON FRIDAY, THEN BY MONDAY THE LCG FAILS EFFICACY. TAC INFORMED THE CUSTOMER THAT THE REPROCESSING SOLUTION HAS A MAXIMUM USAGE OF 5 DAYS. TAC WENT ON TO NOTE THAT PERFORMING LCG ON MONDAY IS A BETTER ALTERNATIVE TO AVOID THE WEEKEND DAYS INTERFERING. TAC MADE SURE TO REVIEW AND CONFIRM THE TEST STRIPS WERE CONSISTENT WITH WHAT IS PROVIDED IN THE INSTRUCTIONS FOR USE (IFU), AND THAT THEY WERE NOT EXPIRED. AFTER CONFIRMING THOSE DETAILS, THE CUSTOMER NOTED THAT SHE FEELS THE ACECIDE SOLUTION IS NOT PASSING THE MRC TEST PREMATURELY. CUSTOMER WENT ON TO NOTE THAT THE LCG PASSES THE MRC ONLY WHEN THE CHEMICAL IS LOADED. AT THIS TIME, THE CUSTOMER IS INTENDING TO PERFORM THE LOAD LCG ON MONDAYS INSTEAD OF FRIDAYS. THE DEVICE HAS NOT BEEN RETURNED. SHOULD ADDITIONAL INFORMATION BE PROVIDED PRIOR TO THE CONCLUSION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW THIS IS NOT A REPORTABLE MALFUNCTION. PER THE LEGAL MANUFACTURER THERE IS NO POTENTIAL FOR THIS ISSUE TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT WHILE REPROCESSING, THE OLYMPUS ENDOSCOPE REPROCESSOR WAS FAILING THE ACECIDE EFFICACY PREMATURELY. THIS EVENT OCCURRED DURING REPROCESSING AND HAVE NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1491920 ENDOSCOPE REPROCESSOR ENDOSCOPE REPROCESSOR FEB OLYMPUS MEDICAL SYSTEMS CORP. OER-ELITE 04953170404047

    Patients

    Seq Age Sex Outcome Treatment
    1