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SPiN Thoracic Navigation System recallZ-1103-2023 · Olympus Corporation of the Americas · initiated Dec 13, 2022

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

A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect DVI cable supplied may result in prolonged procedure/surgery due to additional time to troubleshoot the device

FDA root cause category: Under Investigation by firm

What the company is doing

Olympus issued URGENT - Medical Device Field Corrective Action letter on 12/13/22. Letter states reason for recall, health risk and action to take: 1. Notify your users about this issue and stop using the single-use bronchoscopes (models INS-7100 or INS-7130) with SYS-4000 system until cable is replaced. Your users can continue to use the SYS-4000 using a reusable bronchoscope, with its respective video processor, without affecting their electromagnetic navigation (EMN) procedural experience. 2. Olympus requests that you acknowledge receipt of this letter by accessing the Olympus recall portal. Go to https://olympusamerica.com/recall. Enter the recall number 0418 Provide your contact information as indicated in the portal. An Olympus Field Service Representative will contact you to schedule a site visit to replace the DVI cable. 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, including patient injuries and adverse events, to Olympus. Please report complaints 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.

Recall details

Recall number
Z-1103-2023
Status
Open, Classified
Initiated by the company
Dec 13, 2022
Posted by the FDA
Feb 7, 2023
Recalling firm
Olympus Corporation of the Americas
Quantity
13 units
Product code
JAK
FDA submissions
K170023
Distribution
FL, GA, IN, MD, MS, NY, OH, PA, RI, SC, VA

Product description

SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)

Code information (models, lots, serial numbers)

UDI: 00815686020101 Serial Numbers: 85330200430, 87896220519, 87899220524, 87379210921, 87835220505, 87832220502, 87767220420, 87777220415, 87827220427, 87736220412, 87891220517, 87864220509, 87738220412

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

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

Sources and updates

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