—#188700

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

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K081766
Affected lot / code info: Lot number KR121617

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy PO Box 610, Center Valley, Pennsylvania 18034-0610

Distribution

Distribution pattern: US Nationwide distribution in the states of CA, GA, MN, TN.

Timeline

Recall initiated: 2021-06-09
Terminated: 2023-02-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188700. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.