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U.S. Department of Health and Human Services

Class 2 Device Recall POWERSEAL Curved Jaw Sealer and Divider, Double Action

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  Class 2 Device Recall POWERSEAL Curved Jaw Sealer and Divider, Double Action see related information
Date Initiated by Firm March 07, 2024
Date Posted April 30, 2024
Recall Status1 Open3, Classified
Recall Number Z-1701-2024
Recall Event ID 94375
510(K)Number K212643  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic.

Model/Catalog Number: PS-0544CJDA
Code Information UDI-DI:00821925044579 Lot Code: CA179370
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information Contact Cynthia Ow
647-9993203
Manufacturer Reason
for Recall		 Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.
FDA Determined
Cause 2		 Process control
Action Olympus issued Urgent Medical Device Removal Letter on April 2, 2024 via email/visit. Letter states reason for recall, health risk and action to take: 1. Inspect your inventory and identify any POWERSEAL products having the lot number identified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. Quarantine and cease use of the affected model/lots. 2. Please contact Customer Service at at 1-800-848-9024, option 2, with the quantity, model and lot number of the affected device(s). Olympus will issue a Return Material Authorization to return any affected product at no charge. Olympus will issue a credit to your facility upon return of the affected product. 3. Access the Olympus recall portal to indicate that you have received this notification. a. Go to https://olympusamerica.com/recall b. Enter the recall number "0444 . c. Complete the form as instructed and include your account ID number. 4. If you have distributed these devices outside your facility, please provide a copy of this letter to those facilities immediately. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail at Cynthia.Ow@olympus.com
Quantity in Commerce 150 units: (20 units US); (130 units OUS)
Distribution Worldwide distribution - US Nationwide and the countries of AU, CA, HK, KR.
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 = GEI and Original Applicant = Olympus Surgical Technologies America
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