Health product recall

Powerseal Curved Jaw Sealer & Divider Double Action

Brand(s)
Last updated

Summary

Product
Powerseal Curved Jaw Sealer & Divider Double Action
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Powerseal Curved Jaw Sealer & Divider Double Action

More than 10 numbers, contact manufacturer.

PS-0523CJDA
PS-0537CJDA
PS-0544CJDA

Issue

Olympus conducted an investigation after receiving seven complaints globally regarding parts moving freely on the shaft of the device. Through the investigation, Olympus identified that certain lot numbers of Powerseal may have 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 which affects the ability for the rotation knob to rotate the jaws of the device relative to the handle. The jaws may still be rotated by directly rotating the shaft of the device.

Recall start date: July 27, 2022
 

Additional information

Details
Original published date: 2022-08-24
Alert / recall type
Health product recall
Category
Health product - Medical device - General and plastic surgery
Companies

Gyrus Acmi, Inc

9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64492