Recall Z-2380-2021— Olympus Corporation of the Americas
Class II · Terminated
Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2021-06-09, terminated 2023-02-17. It names one FDA 510(k) clearance: K081766. 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: 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..
- Recalling firm
- Olympus Corporation of the Americas
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-06-09
- Terminated
- 2023-02-17
- Firm location
- Center Valley, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.