—#200667

Product

Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga 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-5450

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K122106, K170023
Affected lot / code info: UDI-DI: 00815686020651 Lot Number: 04541200528 and below

Why it was recalled

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

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

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

Timeline

Recall initiated: 2023-05-15
Posted by FDA: 2023-07-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #200667. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.