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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus

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  Class 2 Device Recall Olympus see related information
Date Initiated by Firm June 09, 2021
Create Date August 27, 2021
Recall Status1 Terminated 3 on February 17, 2023
Recall Number Z-2380-2021
Recall Event ID 88448
510(K)Number K081766  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation
Ref: 970010PC
Code Information Lot number KR121617
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
PO Box 610
Center Valley PA 18034-0610
For Additional Information Contact SAME
484-896-5000
Manufacturer Reason
for Recall		 Expired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic reaction within the patient and / or electrical continuity to patient causing tissue burn to critical structures.
FDA Determined
Cause 2		 Process control
Action Olympus issued Urgent Medical Device Recall Letter on June 9th 2021 via Federal Express two day mail. Letter states reason for recall, health risk and action to take: 1. Immediately cease any further use of any affected product you have, remove it from your inventory and quarantine it until it is shipped back to us. 2. Call your Olympus customer service representative at 1-888-524-7266 option 1. Olympus will issue a Return Material Authorization to return any affected product. at no charge to you. Olympus will issue a credit or replacement to your facility for your 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 Recall-0395 and provide your contact information as indicated in the portal. In addition, if you have further distributed this product, please identify your customers, notify them at once of this product recall, and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Contact me directly at 484-896-5688 or at laura.storms@olympus.com for any additional information concerning this matter.
Quantity in Commerce 6 boxes (5 per/box)=30 units
Distribution US Nationwide distribution in the states of CA, GA, MN, TN.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = GYRUS-ACMI L.P.
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