Class 2 Device Recall SPiN Thoracic Navigation System

• Date Initiated by Firm: May 15, 2023
• Date Posted: July 28, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2263-2023
• Recall Event ID: 92383
• 510(K)Number: K122106 K170023
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval 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-0362
• Code Information: UDI-DI: 00815686020552 Lot Numbers: 05010210512 and below
• Recalling Firm/ Manufacturer: Olympus Corporation of the Americas; 3500 Corporate Pkwy; Center Valley PA 18034-8229
• For Additional Information Contact: SAME; 484-896-5000
• Manufacturer Reason for Recall: 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
• FDA Determined Cause: Component design/selection
• 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 Cynthia.Ow@Olympus.com for any additional information or support concerning this matter.
• Quantity in Commerce: 254.4 units
• Distribution: Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: CN, DE, HK, IT, KR, SG, TH & TW.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JAK and Original Applicant = VERAN MEDICAL TECHNOLOGIES, INC.