Olympus Corporation of the Americas: 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

Agency Publication Date: July 28, 2023

Affected Products

Product: Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated 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-0372

UDI-DI: 00815686020576 Lot Numbers: 05456220113 and below

Lot Numbers:

Numbers

Product: Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing Model: INS-0352

UDI-DI: 00815686020538 Lot Numbers: 04865230201 and below

Lot Numbers:

Numbers

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

UDI-DI: 00815686020552 Lot Numbers: 05010210512 and below

Lot Numbers:

Numbers

Product: Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-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-0382

UDI-DI: 00815686020590 Lot Numbers: 04992210324 and below

Lot Numbers:

Numbers

Product: Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-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-0392

UDI-DI: 00815686020613 Lot Number: 04991210310 and below

Lot Numbers:

Number

Product: Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-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-5300

UDI-DI:00815686021207 Lot Number: 04617200805 and below

Lot Numbers:

Number

Product: Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Needle, 12mm L, 1.8mm OD-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-5410

UDI-DI: 00815686020637 Lot Number: 06332230201 and below

Lot Numbers:

Number

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

UDI-DI: 00815686020651 Lot Number: 04541200528 and below

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92383

Status: Active

Manufacturer: Olympus Corporation of the Americas

Manufactured In: United States

Units Affected: 8 products (1816.2 units; 254.4 units; 3692.2 units; 526.4 units; 1158 units; 759.8 units; 1908.2 units; 144 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

UDI-DI: 00815686020576 Lot Numbers: 05456220113 and below

Lot Numbers:

Numbers

UDI-DI: 00815686020538 Lot Numbers: 04865230201 and below

Lot Numbers:

Numbers

UDI-DI: 00815686020552 Lot Numbers: 05010210512 and below

Lot Numbers:

Numbers

UDI-DI: 00815686020590 Lot Numbers: 04992210324 and below

Lot Numbers:

Numbers

UDI-DI: 00815686020613 Lot Number: 04991210310 and below

Lot Numbers:

Number

UDI-DI:00815686021207 Lot Number: 04617200805 and below

Lot Numbers:

Number

UDI-DI: 00815686020637 Lot Number: 06332230201 and below

Lot Numbers:

Number

UDI-DI: 00815686020651 Lot Number: 04541200528 and below

Lot Numbers:

Number