Recall Z-2380-2021 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Olympus Corporation of the Americas
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
| Date | Jun 9, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | Olympus issued Urgent Medical Device Recall Letter on June 9th 2021 via Federal Express two day mail. Letter states reason for recall, health risk and action to take: 1. Immediately cease any further use of any affected product you have, remove it from your inventory and quarantine it until it is shipped back to us. 2. Call your Olympus customer service representative at 1-888-524-7266 option 1. Olympus will issue a Return Material Authorization to return any affected product. at no charge to you. Olympus will issue a credit or replacement to your facility for your affected product. 3. Access |
| Quantity | 6 boxes (5 per/box)=30 units |
| Distribution | US Nationwide distribution in the states of CA, GA, MN, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081766 | PKS OMNI INSTRUMENT Gyrus-Acmi L.P., Aug 8, 2008 |