Olympus Corporation of the Americas: Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. 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.

Recall number

Z-2339-2025

Recalling firm

Olympus Corporation of the Americas

Product

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. 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.

Status

Open, Classified

Initiated

2025-07-25

Posted

2025-08-19

Terminated

not on file

Reason

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

Component change control

Action

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.

Quantity

434 units

Distribution

US Nationwide distribution.

Lot, serial or model codes

Model Number: WA91307C. Lot Code: ESG-410 Legacy WA91307C. UDI-DI: 04042761086349. Serial Numbers: 101004, 101005, 101006, 101007, 101008, 101009, 101010, 101011, 101012, 101013, 101014, 101015, 101016, 101017, 101018, 101019, 101020, 101021, 101022, 101023, 101024, 101025, 101029, 101030, 101031, 101032, 101033, 101034, 101035, 101036, 101037, 101038, 101039, 101040, 101041, 101042, 101043, 101044, 101045, 101046, 101047, 101048, 101049, 101050, 101051, 101052, 101053, 101054, 101055, 101056, 101057, 101058, 101059, 101060, 101061, 101062, 101063, 101064, 101066, 101067, 101068, 101069, 101070, 101071, 101072, 101073, 101074, 101238, 101239, 101240, 101241, 101242, 101243, 101244, 101245, 101246, 101247, 101250, 101251, 101252, 101253, 101254, 101255, 101256, 101257, 101258, 101259, 101260, 101261, 101262, 101263, 101264, 101265, 101266, 101267, 101268, 101269, 101270, 101271, 101272, 101273, 101274, 101275, 101276, 101277, 101278, 101279, 101280, 101281, 101282, 101283, 101284, 101285, 101286, 101287, 101288, 101289, 101290, 101291, 101292, 101293, 101294, 101295, 101296, 101297, 101298, 101299, 101300, 101301, 101302, 101333, 101334, 101335, 101336, 101337, 101338, 101339, 101340, 101341, 101342, 101370, 101371, 101372, 101373, 101374, 101375, 101376, 101377, 101378, 101379, 101395, 101396, 101397, 101398, 101399, 101400, 101401, 101402, 101403, 101432, 101433, 101434, 101435, 101436, 101437, 101438, 101439, 101440, 101441, 101613, 101633, 101634, 101635, 101636, 101637, 101638, 101684, 101685, 101686, 101687, 101688, 101689, 101691, 101690, 101692, 101693, 101694, 101695, 101743, 101744, 101745, 101746, 101747, 101748, 101749, 101750, 101751, 101752, 101753, 101754, 101755, 101756, 101757, 101758, 101759, 101760, 101761, 101762, 101763, 101764, 101765, 101766, 101767, 101768, 101769, 101770, 101771, 101772, 101773, 101774, 101775, 101776, 101777, 101778, 101779, 101780, 101781, 101782, 101783, 101784, 101785, 101786, 101787, 101788, 101789, 101958, 101959, 101960, 101961, 101962, 101963, 101964, 101965, 101966, 101967, 101968, 101969, 101970, 101971, 102017, 102018, 102019, 102020, 102021, 102024, 102025, 102026, 102027, 102028, 102055, 102056, 102057, 102058, 102059, 102060, 102061, 102062, 102063, 102064, 102065, 102066, 102067, 102068, 102069, 102284, 102285, 102286, 102287, 102288, 102289, 102290, 102291, 102292, 102293, 102294, 102295, 102296, 102297, 102298, 102299, 102300, 102301, 102302, 102303, 102304, 102305, 102306, 102307, 102308, 102309, 102310, 102311, 102312, 102313, 102314, 102315, 102316, 102317, 102318, 102319, 102320, 102321, 102323, 102325, 102326, 102327, 102328, 102329, 102330, 102331, 102332, 102333, 102334, 102335, 102362, 102363, 102364, 102366, 102367, 102368, 102369, 102370, 102371, 102372, 102373, 102391, 102392, 102393, 102394, 102395, 102396, 102397, 102399, 102400, 102401, 102402, 102403, 102404, 102405, 102406, 102407, 102408, 102409, 102410, 102411, 102412, 102413, 102414, 102415, 102416, 102417, 102418, 102419, 102420, 102421, 102422, 102423, 102424, 102425, 102426, 102428, 102429, 102430, 102431, 102432, 102433, 102434, 102435, 102436, 102437, 102438, 102439, 102440, 102441, 102442, 102443, 102444, 102445, 102497, 102498, 102499, 102500, 102501, 102502, 102503, 102504, 102505, 102506, 102507, 102508, 102509, 102510, 102511, 102512, 102513, 102515, 102516, 102517, 102518, 102519, 102520, 102521, 102522, 102523, 102802, 102807, 102808, 102809, 102810, 102814, 102818, 102819, 102820, 102821, 102822, 102823, 102828, 102829, 102830, 102831, 102832, 102834, 102836, 102837.

510(k) numbers

["K203277"]

PMA numbers

not on file

Product code

GEI

Firm FEI

2429304

Firm city

Center Valley

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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