[Recalled] EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190 — There is a risk of endobronchial combustion if high-frequency cauterization is… | FDA 2023-10-12

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).

Read the full official notice →

Related recalls from Olympus Corporation of the Americas

• Olympus Bronchovideoscope, Models BF-3C40 & BF-N20. — Class II
• Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract. — Class II
• Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current. — Class II
• Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current. — Class II
• Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U — Class II
• Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2 — Class I

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.