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Always-On Tip Tracked Instruments (SPiN Drive instruments)… recallZ-2269-2023 · Olympus Corporation of the Americas · initiated May 15, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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

FDA root cause category: Component design/selection

What the company is doing

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.

Recall details

Recall number
Z-2269-2023
Status
Open, Classified
Initiated by the company
May 15, 2023
Posted by the FDA
Jul 28, 2023
Recalling firm
Olympus Corporation of the Americas
Quantity
144 units
Product code
JAK
FDA submissions
K122106, K170023
Distribution
Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: CN, DE, HK, IT, KR, SG, TH & TW.

Product description

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

Code information (models, lots, serial numbers)

UDI-DI: 00815686020651 Lot Number: 04541200528 and below

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

29 devices cleared under K122106, K170023 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 92383).

Sources and updates

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