EVIS EXERA BRONCHOVIDEOSCOPE recallZ-2014-2023 · Olympus Corporation of the Americas · initiated Jun 8, 2023

Why it was recalled

There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

FDA root cause category: Under Investigation by firm

What the company is doing

An "URGENT MEDICAL DEVICE CORRECTIVE ACTION" notification letter dated 6/8/23 was sent to customers. Actions to be taken by the company: The labelling will be updated to include specificity about laser compatibility, improved instructions regarding patient preparation, and warnings about patient injury and death resulting from incompatible laser use. Actions to be taken by the end user: 1. Inspect your inventory for the referenced devices and identify any device with the model names. Please check all areas of the hospital to determine if any of these devices remain in inventory. 2. Carefully read the content of this Medical Device Correction Action as well as the attached Addendum . The addendum provides compatible laser type. 3. Ensure all personnel are completely knowledgeable and thoroughly aware that Olympus laser compatible bronchoscopes are compatible only with Nd: YAG laser or 810 nm diode lasers. 4. Olympus requests that you acknowledge receipt of this letter through the Olympus recall portal. a. Go to https://olympusamerica.com/recall b. Enter the file (recall) number: 0427 5. If you have further distributed this product, identify your customers, forward them this notification, and appropriately document your notification process. Olympus requests that you report complaints, including any injuries associated with laser procedures with Olympus bronchoscopes, to our Technical Assistance Center (TAC) at 1-800-848-9024 (option 1). Adverse events experienced with the use of this product may also be reported to the Food and Drug Administration MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Olympus regrets any inconvenience caused and fully appreciates your cooperation in this matter. Please do not hesitate to call (647) 999-3203 or email: at [email protected] for any additional information or support concerning this matter.

Recall details

Recall number

Z-2014-2023

Status

Open, Classified

Initiated by the company

Jun 8, 2023

Posted by the FDA

Jul 17, 2023

Recalling firm

Olympus Corporation of the Americas

Quantity

284 units

Product code

EOQ

FDA submissions

K023984

Distribution

US Nationwide Distribution.

Product description

Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160

  Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)
  4 recalls1 death41 reports

Product lines

• EVIS EXERA BRONCHOVIDEOSCOPEOlympus Medical Systems Corp. · 3 models · 91 reports · 6 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 92362).

• Z-2011-2023 · Open, Classified
  Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60
• Z-2012-2023 · Open, Classified
  Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
• Z-2013-2023 · Open, Classified
  Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150
• Z-2015-2023 · Open, Classified
  Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170
• Z-2016-2023 · Open, Classified
  Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180
• Z-2017-2023 · Open, Classified
  Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190