Agency classClass IIOur severity:High FDA (Devices)·Z-2263-2023·Announced 2023-08-09

Olympus Forceps Model INS-0362 Navigation Sensor Malfunction During Procedures

Always-On Tip Tracked Instruments forceps (Model INS-0362) may experience electromagnetic sensor tracking malfunction during endobronchial procedures, impairing navigation functionality and causing procedural delays.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall with no reported injuries or illnesses. The EM sensor tracking malfunction impairs critical navigation functionality during procedures, meeting the rubric criterion for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, Model INS-0362. These forceps have a 1.8 mm oval cup design and are used in clinical interventions where computed tomography and endoscopic bronchoscopy are used for visualization during procedures.

The electromagnetic (EM) sensor tracking system on the forceps may malfunction during endobronchial procedures. When this occurs, the navigation functionality is impaired and the system displays a coil break warning message, potentially resulting in procedural delays.

The recall affects approximately 254.4 units distributed worldwide, including throughout the United States and internationally to China, Germany, Hong Kong, Italy, South Korea, Singapore, Thailand, and Taiwan. Affected units are identified by lot numbers 05010210512 and below (UDI-DI: 00815686020552).

The recalled product

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…
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Surgical Forceps
Hazard: sensor-malfunction
navigation-impairment

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

UDI-DI: 00815686020552 Lot Numbers: 05010210512 and below

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 8 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

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