Date Initiated by Firm | August 12, 2022 |
Date Posted | September 26, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1815-2022 |
Recall Event ID |
90788 |
510(K)Number | K212643 |
Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
|
Product | Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION
Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures. |
Code Information |
UDI-DI: 00821925044579
Lot Numbers:
CA191182
CA191183
CA191184
CA191185
CA191186
CA236235
CA236237
FR230559 |
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 | 44 units (5/box); 133 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.
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510(K) Database | 510(K)s with Product Code = GEI
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