BEUDAMED
    FDA Recall Open, Classified

    Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-0372

    Recall: Z-2264-2023 · Initiated May 15, 2023

    Recall

    Recall Number
    Z-2264-2023
    Event Number
    92383
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    JAK
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    May 15, 2023
    Posted
    July 28, 2023
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-0372

    Reason

    Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay

    Action

    Olympus issued "URGENT - Medical Device Field Corrective Action" on 5/15/23. Letter states reason for recall, health risk and action to take: Olympus implemented a new internal component and has observed a reduction in complaints for the above-mentioned issue. However, to minimize the duration of potential procedure delay, Olympus is revising the Instruction for Use to add the below precaution statement: It is required to have additional Always-On Tip Tracked instruments available for all procedures as tracking may be lost when: Connecting the instrument to the SPiN Thoracic Navigation System Inserting and withdrawing the instrument from the working channel of the bronchoscope during procedure Navigating and sampling in tortuous patient anatomy Action steps to be taken by the end user: Our records indicate that you have purchased one or more of the affected products. Olympus requires you to take the following action: 1. Notify and ensure your users are knowledgeable about this additional precaution requiring additional instruments be available for all procedures. 2. Olympus requests that you acknowledge receipt of this letter by accessing the Olympus recall portal. a) Go to https://olympusamerica.com/recall. b) Enter the recall number 0425 c) Complete the form as instructed. 3. If you have distributed these devices outside your facility, please notify your customers of this matter immediately. Your notification to your customers may be enhanced by including a copy of this letter. Olympus requests that you report complaints associated with the use of this device, including patient injuries and adverse events, to our Technical Assistance Center (TAC) at 1-800-848-9024 (option 1 to report complaints). Contact (647) 999-3203 or at [email protected] for any additional information or support concerning this matter.

    Distribution

    Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: CN, DE, HK, IT, KR, SG, TH & TW.

    Quantity

    3692.2 units