Recall Z-2415-2024 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Olympus Corporation of the Americas
ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries Model/Catalog Number: WA91307C
| Date | Jul 23, 2024 (initiated Jun 21, 2024) |
| Status | Open, Classified |
| Reason | Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating treatment or prolonged surgery |
| Root cause | Component design/selection |
| Action | Olympus issued URGENT: MEDICAL DEVICE REMOVAL Letter on 6/21/24. Letter states reason for recall, health risk and action to take: An Olympus representative will reach out to you to coordinate a repair to replace the power supply on your affected ESG-410 unit(s). Technical analysis of this issue performed by Olympus has determined that when the device is successfully powered on, it will work within specification. Therefore, you may continue to use your ESG-410 generator until the power supply is replaced. To minimize procedural delays, power on the generator prior to starting the procedure and, |
| Quantity | 86 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps Olympus Winter & Ibe GmbH, Apr 28, 2021 |