—#214934

Product

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K231777
Affected lot / code info: Model Number: WA91327U. Lot Code: ESG-410 (SEP) WA91327U. UDI-DI: 04042761087698. Serial Numbers: 101696, 101697, 101698, 101699, 101700, 101701, 101702, 101703, 101704, 101705, 101706, 101707, 101708, 101709, 101710, 101919, 101920, 101921, 101922, 101923, 101924, 101925, 101926, 101927, 101928, 101929, 101933, 101934, 101935, 101936, 101937, 101940, 101941, 101942, 101945, 101946, 101947, 102148, 102149, 102150, 102151, 102152, 102153, 102154, 102156, 102157, 102158, 102159, 102160, 102161, 102162, 102164, 102165, 102167, 102168, 102170, 102172, 102173, 102174, 102175, 102176, 102177, 102178, 102179, 102180, 102181, 102182, 102183, 102184, 102185, 102186, 102187, 102188, 102189, 102190, 102191, 102193, 102194, 102195, 102198, 102199, 102200, 102266, 102427, 101932, 102155, 102163, 102197, 102660, 102661, 102662, 102663, 102664, 102665, 102666, 102667, 102668, 102669, 102670, 102671, 102672, 102673, 102674, 102675, 102676, 102677, 102678, 102679, 102680, 102681, 102682, 102683, 102684, 102685, 102686, 102687, 102688, 102689, 102690, 102691, 102692, 102693, 102694, 102695, 102696, 102697, 102698, 102699, 102700, 102701, 102702, 102703, 102704, 102705, 102706, 102707, 102708, 102709, 102710, 102711, 102712, 102713, 102714, 102715, 102716, 102717, 102718, 102719, 102721, 102722, 102723, 102724, 102725, 103922, 103930.

Why it was recalled

Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.

Root cause (FDA determination)

Component change control

Action the firm took

Olympus notified consignees via letter on about 07/25/2025. Consignees were instructed to examine inventory, identify any affected units, and continued use is permitted until the repair is performed as long as users follow the IFU. Olympus will contact consignees to arrange for the return of affected units to replace the affected part. Consignees were also instructed to notify customers, if the units were further distributed, and to acknowledge receipt of the letter through the Olympus web portal.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2025-07-25
Posted by FDA: 2025-08-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #214934. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.