BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REUT-BOB W/O WR .050" [ORIG ITEM: 145209] (6/PK)

    MDR report key: 22366919 · Received June 30, 2025

    Report

    Report Number
    1037007-2025-00007
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    June 11, 2025
    Report Date
    October 23, 2025
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    ETD
    PMA / PMN Number
    K820362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4 - EXPIRATION DATE, G1, H2, H6, H11. CORRECTED FIELDS: D4 - LOT #, D4 - SERIAL #, D4 UNIQUE DEVICE IDENTIFIER (UDI) #1, D6A - IMPLANT DATE, D6B, D7A, D10, H5. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE DEVICE'S FINAL INVESTIGATION. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION; HOWEVER, A PICTURE WAS PROVIDED BY THE CUSTOMER, AND THE REPORTED FAILURE WAS CONFIRMED. THE PHOTO SHOWS THE EXPIRATION DATE OF AUGUST 2012. THE MOST PROBABLE CAUSE OF THE COMPLAINT IS PARTIALLY OR WHOLLY DUE TO THE USER OF THE DEVICE, INCLUDING SAMPLE HANDLING. THE LABELING REVIEW WAS CONDUCTED. THE DEVICE WAS NOT USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU), PN0017494_AD, AS IT WAS USED AFTER THE LABELED EXPIRATION DATE. THE IFU HAS: - PAGE 1, "HOW SUPPLIED: GYRUS ENT¿S VENTILATION TUBES ARE PROVIDED STERILE." - LABEL SYMBOLS: ¿USE BY ¿¿ (EXPIRATION DATE SYMBOL). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED AN EXPIRED VENTILATION TUBE WAS INSERTED INTO THE PATIENT'S EAR. THE REPORTED ISSUE OCCURRED DURING A THERAPEUTIC MYRINGOTOMY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262423 REUT-BOB W/O WR .050" [ORIG ITEM: 145209] (6/PK) TUBE, TYMPANOSTOMY ETD GYRUS ACMI, INC. 145209-ENT 0234862808

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown