Olympus Corporation of the Americas Recall 88448
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
Olympus Corporation of the Americas Recall 88448 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2380-2021 |
| Event ID | 88448 |
| Event 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of CA, GA, MN, TN. |
| Quantity | 6 boxes (5 per/box)=30 units |
| Recall 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. |
| Device Classification | 20210908 |
| Device Code Info | Lot number KR121617 |
| Center Classification Date | 20210827 |
| Recall Initiation Date | 20210609 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
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