—#195726

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.

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K212643
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA

Timeline

Recall initiated: 2022-08-12
Posted by FDA: 2022-09-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #195726. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.