BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMMINGBIRD TYMPANOSTOMY TUBE SYSTEM

    MDR report key: 19455287 · Received June 3, 2024

    Report

    Report Number
    3010610937-2024-00001
    Event Type
    Injury
    Date Received
    June 3, 2024
    Date of Event
    April 23, 2024
    Report Date
    May 31, 2024
    Manufacturer
    PRECEPTIS MEDICAL, INC.
    Product Code
    ETD
    UDI-DI
    00853386007077
    PMA / PMN Number
    K221254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INTERNAL COMPLAINT REFERENCE FOR THIS INCIDENT IS (B)(4). THE INSERTION DEVICE INVOLVED WAS DISCARDED BY THE CUSTOMER AND IS NOT AVAILABLE FOR EVALUATION. PATIENT MOTION DURING THE PROCEDURE IS A KNOWN RISK OF THE IN-OFFICE EAR TUBE PROCEDURE. INSTRUCTIONS FOR USE AND CLINICIAN TRAINING PROCESS BOTH ADDRESS THE NEED FOR PATIENT STABILIZATION DURING THE PROCEDURE. RISK MANAGEMENT REVIEW WAS CONDUCTED AND THE REPORTED HARM HAS BEEN APPROPRIATELY DOCUMENTED IN THE RISK MANAGEMENT FILE. DHR AND COMPLAINT REVIEW FOR THE LOT NUMBER INVOLVED DID NOT REVEAL ANY ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS INCIDENT.

    Description of Event or Problem · 0

    CLINICIAN REPORTED PLACING EAR TUBES IN HER CLINIC IN A 4-YEAR OLD FEMALE PATIENT USING THE HUMMINGBIRD TYMPANOSTOMY TUBE SYSTEM. THE SYSTEM WAS USED TO SUCCESSFULLY PLACE A TYMPANOSTOMY TUBE (TT) IN THE FIRST EAR. IN THE SECOND EAR, THE CHILD'S HEAD MOVED SLIGHTLY DURING THE PROCEDURE, CAUSING THE TUBE TO BE DELIVERED MEDIALLY INTO THE MIDDLE EAR SPACE. THE CLINICIAN ATTEMPTED TO RETRIEVE THE TT, BUT WAS NOT ABLE TO EXTRACT IT DURING THE PROCEDURE IN THE OFFICE. AN OPERATING ROOM FOLLOW-UP TO LOCATE AND EXTRACT THE TUBE UNDER GENERAL ANESTHESIA WAS SCHEDULED. THE FOLLOW-UP PROCEDURE WAS NOT ABLE TO LOCATE THE TT IN THE MIDDLE EAR SPACE. THE DOCTOR REPORTS THAT PATIENT HAS NO SYMPTOMS RELATED TO THE MEDIALIZED TUBE AND THERE IS NO ADVERSE IMPACT ON PATIENT HEARING. PATIENT WILL BE MONITORED FOR SYMPTOMS AND APPROPRIATE ACTION TAKEN IF ANY OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264409 HUMMINGBIRD TYMPANOSTOMY TUBE SYSTEM TYMPANOSTOMY TUBE AND INSERTER ETD PRECEPTIS MEDICAL, INC. 05-1001-653 L-1101818 00853386007077

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Female Other