| Date Initiated by Firm |
October 12, 2023 |
| Date Posted |
November 09, 2023 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0193-2024 |
| Recall Event ID |
93052 |
| 510(K)Number |
K183419
|
| Product Classification |
Bronchoscope (flexible or rigid) - Product Code EOQ
|
| Product |
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190 |
| Code Information |
Model BF-XT190 UDI-DI: 4953170402470
|
Recalling Firm/
Manufacturer |
Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
|
| For Additional Information Contact |
Cynthia Ow
484-896-5000
|
Manufacturer Reason
for Recall |
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.
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
An "URGENT MEDICAL DEVICE CORRECTIVE ACTION" notification letter dated 10/12/23 was sent to customers.
Actions to be taken by the end user:
Our records indicate that your facility has purchased one or more of the affected bronchoscopes. Olympus requests you to take the following actions:
1. Inspect your facility for the referenced devices and ensure all personnel are completely knowledgeable and thoroughly aware of the Warnings in affected bronchoscope s Operation Manual for use with High-frequency therapy equipment and that Olympus high-frequency compatible bronchoscopes are compatible only with Combination equipment list in operation manual. You may continue to use the device according to the existing instructions and warnings contained in the Instruction for Use.
2. Complete the enclosed response form and return to our recall partner, Sedgwick, via Email (Olympus4907@sedgwick.com) or Fax (866-808-1177). For any questions about the acknowledgement form, please call the Sedgwick team at 855-215-5128.
3. If you have further distributed this product outside of your facility, forward them this notification and appropriately document your notification process.
Olympus requests that you report to Olympus complaints, including any injuries associated with procedures involving energy devices used with Olympus bronchoscopes. Please report complaints to the Olympus 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 contact me directly at (647) 999-3203 or at Cynthia.Ow@Olympus.com for any additional information or support concerning this matter. |
| Quantity in Commerce |
719 devices |
| Distribution |
US Nationwide distribution |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database |
510(K)s with Product Code = EOQ and Original Applicant = Olympus Medical Systems Corp.
|
