The Recall Desk
HighFDA (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.

What this means for you

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: INS-0362
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.

Related recalls

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