BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARM BEV VENT TB FLPL .045 [ORIG ITEM: 140242] (6/PK)

    MDR report key: 16742660 · Received April 14, 2023

    Report

    Report Number
    3003790304-2023-00153
    Event Type
    Injury
    Date Received
    April 14, 2023
    Report Date
    June 20, 2024
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    JYM
    UDI-DI
    00821925035027
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN LESS THAN 1 YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, ALTHOUGH THE CUSTOMER REPORTED THAT THE TUBE FELL INTO THE PATIENT¿S MIDDLE EAR, ALL SIX DEVICES RETURNED FOR AN EVALUATION WERE UNUSED. THEREFORE, IT IS LIKELY THAT THE SUBJECT DEVICE BELONGED TO ANOTHER BOX OF DEVICES. DUE TO THIS, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THIS SUPPLEMENTAL REPORT INCLUDES INFORMATION ADDED TO H4. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 0

    OLYMPUS RECEIVED A BOX OF THE DEVICES, BUT HAS NOT YET RECEIVED THE COMPLAINT DEVICE. THE OUTER BOX ALREADY WAS OPENED, BUT ALL THE 6 STERILE PACKETS INSIDE ARE BRAND NEW AND STILL IN SEALED CONDITION. EACH VENT TUBE WAS EXAMINED UNDER A MICROSCOPE AND FOUND NO APPEARANCE ABNORMALITIES. A MEASUREMENT WAS TAKEN INSIDE THE TUBE¿S DIAMETER BY USING A TEST CALIPER, READING AT 1.14MM WHICH IS WITHIN THE INNER DIAMETER SPECIFICATION. THE BEVELED INNER FLANGE, HOLLOW CYLINDER AND ITS RIMS APPEARED TO BE STURDY WHEN PRESSED DOWN WITH TWEEZERS. THE DEVICE CAN STAND UPRIGHT FIRMLY ON EITHER SIDE WITHOUT AN ISSUE. BASED ON THE EVALUATION FINDINGS, THE REPORTED COMPLAINT WAS NOT CONFIRMED. THE DEVICE MET ITS SPECIFICATION. THE INVESTIGATION IS ONGOING AND FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THAT THE SURGEON DID NOT LIKE THE ARM BEV VENT TB FLPL .045 DEVICE AS THE RIM THAT HELD THE EAR TUBE IN PLACE WAS NOT STURDY ENOUGH. WHEN ASKED FURTHER, IT WAS STATED THAT ON ONE OCCASION IN NOVEMBER OR DECEMBER OF 2022, THE TUBE HAD FALLEN INTO A HOLE IN THE EARDRUM. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143747 ARM BEV VENT TB FLPL .045 [ORIG ITEM: 140242] (6/PK) INSERTER, MYRINGOTOMY TUBE JYM GYRUS ACMI, INC. 140242-ENT 341697 00821925035027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention