ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation

FDA device recall Z-2415-2024 · posted 2024-07-23 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

Reason for recall

Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating treatment or prolonged surgery

Action taken

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, whenever possible, have a replacement device available. Additionally, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. If you have further distributed this product, identify your customers, and forward them this notification. 3. Acknowledge receipt of this letter through the Olympus web portal: a. Go to https://olympusamerica.com/recall Olympus requests that you report any complaints, including the ESG-410 generator not powering on, to the Technical Assistance Center (TAC) at 1- 800-848-9024 (option 1). If you require additional information, please do not hesitate to contact me by phone at (647) 999-3203 from Monday through Friday, 9 am to 5 pm EDT, or by e-mail at Cynthia.Ow@olympus.com.

Root cause

Component design/selection

Status

Open, Classified

Product code

GEI

Quantity affected

86

Distribution

US Nationwide distribution.

Date initiated

2024-06-21

Date posted

2024-07-23

Location

Center Valley, PA

Related 510(k) clearances