Olympus Bronchovideoscope, Models BF-P190 & BF-XP190.

FDA device recall Z-2500-2023 · posted 2023-08-31 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

Reason for recall

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

Action taken

Consignees were mailed an Urgent Medical Device Correction notification dated 7/27/2023 via UPS. The notification asks that consignees inspect their inventory for recalled devices and check clinical areas to see if any remain in use. Consignees are to ensure that all personnel, including clinical staff, are completely knowledgeable of this recall notification and addendum, which instructs users to slide the endotracheal tube along the entire length of the tracheal intubation scope insertion section to confirm compatibility before using on a patient. Consignees are asked to complete and return the provided response form to Sedgwick via email at Olympus7498@sedgwick.com or by fax at 866-552-4917. Any questions about the acknowledgement form may be directed by phone to 866-737-4762. If product has been further distributed, please forward the notification to those secondary consignees and maintain records of your documentation process. Consignees are to report any complaints to Olympus Technical Assistance Center at 1-800-848-9024 (Option 1) and FDA Medwatch. Any further questions are to be directed to Tara Safi by email at Tara.Safi@Olympus.com.

Root cause

Labeling Change Control

Status

Open, Classified

Product code

EOQ

Quantity affected

3949 units

Distribution

US Nationwide distribution.

Date initiated

2023-07-27

Date posted

2023-08-31

Location

Center Valley, PA

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