FDA-Device2021-09-08Class II
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
Olympus Corporation of the Americas
Hazard
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.
Sold states
US Nationwide distribution in the states of CA, GA, MN, TN.
Affected count
6 boxes (5 per/box)=30 units
Manufactured in
3500 Corporate Pkwy, PO Box 610, Center Valley, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2380-2021Don't want to check this manually?
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