FDA recall Z-2380-2021

Olympus Corporation of the Americas · Class II · device

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

Reason for recall

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2021-06-09
Report date
2021-09-08
Termination date
2023-02-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2380-2021