The Recall Desk
SevereFDA (Devices)·Z-0190-2024·Announced 2023-11-15

Olympus Bronchovideoscope Recall for Combustion Risk with Electrosurgery

Olympus is recalling 1,154 EVIS EXERA II bronchovideoscope units due to risk of endobronchial combustion during high-frequency electrosurgical procedures when oxygen is supplied and electrode placement is inappropriate.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall with serious hazard potential (endobronchial combustion during endoscopic procedure). Agency classification ensures minimum severity score of 4.

Plain-English summary

Olympus Corporation of the Americas is recalling 1,154 EVIS EXERA II BRONCHOVIDEOSCOPE units (Model BF-Q180-AC) distributed nationwide in the United States.

The recall addresses a risk of endobronchial combustion during high-frequency cauterization procedures when oxygen is supplied to the patient and the electrode section of the electrosurgical accessory is positioned too close to the distal end of the endoscope.

This recall affects healthcare facilities and medical professionals who use this bronchovideoscope model in bronchoscopic procedures.

The recalled product

Product
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC
Manufacturer
Olympus Corporation of the Americas
Hazard
  • combustion
  • electrosurgery

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)

  • Model BF-Q180-AC UDI-DI: N/A

Distribution

Distributed nationwide across the United States.