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Class 2 Device Recall SOLTIVE SuperPulsed Laser Fibers |
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Date Initiated by Firm |
December 01, 2023 |
Date Posted |
January 18, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0748-2024 |
Recall Event ID |
93649 |
510(K)Number |
K183647
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Product Classification |
Powered laser surgical instrument - Product Code GEX
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Product |
SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS |
Code Information |
Models UDI/GTIN
TFL-FBX150S 00821925043916
TFL-FBX200S 00821925043930
TFL-FBX365S 00821925043992
TFL-FBX550S 00821925044036
TFL-FBX940S 00821925044074
TFL-FBX150BS 00821925043879
TFL-FBX200BS 00821925043978
All lots affected |
Recalling Firm/ Manufacturer |
Olympus Corporation of the Americas 3500 Corporate Pkwy Center Valley PA 18034-8229
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For Additional Information Contact |
Cynthia Ow 647-999-3203
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Manufacturer Reason for Recall |
Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents the potential for the fiber to break during use, which may cause burns, procedure delays, prolonged surgery, and foreign body in patient.
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FDA Determined Cause 2 |
Labeling Change Control |
Action |
On December 1, 2023, the firm issued URGENT MEDICAL DEVICE CORRECTION letters to affected customers.
Customers were provided with copies of the labeling addendum to add to remaining inventory. Customers may continue to use the product, but this should be done in accordance with the labeling addendum.
If you require additional information, please contact Olympus at (647) 999-3203 or at Cynthia.Ow@Olympus.com. |
Quantity in Commerce |
82,200 total units (5 per box) |
Distribution |
Worldwide distribution - US Nationwide and the countries of Canada, Europe, Hong Kong, Australia, Japan, Singapore, and Latin America. |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = GEX and Original Applicant = Olympus Surgical Technologies America
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