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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLEACTION

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  Class 2 Device Recall Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLEACTION see related information
Date Initiated by Firm August 12, 2022
Date Posted September 26, 2022
Recall Status1 Open3, Classified
Recall Number Z-1814-2022
Recall Event ID 90788
510(K)Number K212643  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION

Model Number: PS-0537CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
Code Information UDI-DI: 00821925044555 Lot Numbers: CA191233 CA191234 CA191235 CA233514 CA233515 CA233516 CA233517 CA233518 CA236206 CA236208 CA236213 CA236215 CA236216 CA236217 CA236220 CA236227 CA236228 CA236230 CA236238 CA236240 CA236243 CA236261 CA236272 CA236273 CA236276 CA236278 CA236290
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information Contact SAME
484-896-5000
Manufacturer Reason
for Recall		 An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment
FDA Determined
Cause 2		 Under Investigation by firm
Action Olympus issued Urgent Medical Device Recall Letter on 8/12/22 to Surgical Department Risk Management. Letter states reason for recall, health risk and action to take: 1. Immediately locate any product with affected lot numbers listed in this communication. See Attachment 2 for pictures showing the location of lot numbers on the package. 2. Call your Olympus customer service representative at 1 800 848 9024, option 2. Olympus will issue a Return Material Authorization to return any affected product at no charge to you. Olympus will issue a credit to your facility upon return of affected product. 3. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number 0412 and provide your contact information as indicated in the portal. 4. If you have distributed these devices outside your facility, please notify your customers of this removal action immediately. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Contact directly at (647) 999-3203 or at Cynthia.Ow@Olympus.com for any additional information or support concerning this matter.
Quantity in Commerce 231.4 units (5/box); 510 units (5/box) OUS
Distribution Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA
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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