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
Z-2380-2021
Product summary
- Event
- Event 88448
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 boxes (5 per/box)=30 units
- Official record key
device-enforcement:Z-2380-2021
Official wording
Reason: 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.
Code information: Lot number KR121617
Distribution pattern: US Nationwide distribution in the states of CA, GA, MN, TN.
Derived failure modes
-
Foreign material or chemical contamination
foreign body