Date Initiated by Firm | December 17, 2018 |
Create Date | March 12, 2019 |
Recall Status1 |
Terminated 3 on November 18, 2020 |
Recall Number | Z-1010-2019 |
Recall Event ID |
82099 |
510(K)Number | K143153 |
Product Classification |
Endoscope, accessories, narrow band spectrum - Product Code NWB
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Product | Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract. |
Code Information |
Serial Number 2506043 and 2619818 |
Recalling Firm/ Manufacturer |
Olympus Corporation of the Americas 3500 Corporate Pkwy PO Box 610 Center Valley PA 18034-0610
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For Additional Information Contact | Laura Storms 484-896-5688 |
Manufacturer Reason for Recall | The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Customers were contacted via telephone on 12/17/18. Customers were also sent notification letters on 1/2/19. |
Quantity in Commerce | 2 |
Distribution | US Nationwide distribution in the states of CT, IL, MN, MO, and NC. |
Total Product Life Cycle | TPLC Device Report |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = NWB
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