Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical de

FDA device recall Z-1815-2022 · posted 2022-09-26 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GEI

Quantity affected

44 units (5/box); 133 units (5/box) OUS

Distribution

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

Date initiated

2022-08-12

Date posted

2022-09-26

Location

Center Valley, PA

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