BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCOPE

    MDR report key: 16138598 · Received January 11, 2023

    Report

    Report Number
    9610595-2023-00608
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    December 13, 2022
    Report Date
    June 11, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    GCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING, AND A DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE MODEL AND SERIAL NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE USER DID NOT READ INSTRUCTIONS FOR USE (IFU) OR DEVIATED FROM THE IFU INTENTIONALLY AND USED DETERGENT OTHER THAN OLYMPUS DESIGNATION. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), DURING REPROCESSING, THE ENDOSCOPE REPROCESSOR EXHIBITED ERROR E05 INDICATING CLEANING FLUID LEVEL WAS TOO HIGH. WHEN AN OLYMPUS FIELD SERVICE ENGINEER (FSE) VISITED THE FACILITY, THE FSE NOTICED CUSTOMER NOT USING ENDOQUICK AND WERE USING A BLUE DETERGENT OF SOME SORT. THIS REPORT IS FOR AN UNKNOWN SCOPE THAT WAS REPROCESSED USING INCORRECT DETERGENT. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. PATIENT IDENTIFIER (B)(6) CAPTURES COMPLAINT ON THE REPROCESSOR THAT WAS USING INCORRECT DETERGENT. (MODEL NO. OER-PRO, SERIAL NO. (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118425 SCOPE ENDOSCOPE, FLEXIBLE GCQ AIZU OLYMPUS CO., LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown