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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus Electrosurgical Generator

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 Class 2 Device Recall Olympus Electrosurgical Generatorsee related information
Date Initiated by FirmSeptember 04, 2024
Date PostedOctober 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0264-2025
Recall Event ID 95477
510(K)NumberK231777 
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
ProductOlympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
Code Information UDI-DI: 04042761087698; Serial Numbers: 101698 102191 102706 103016 103068 103112 103161 103199 101702 102195 102707 103018 103069 103114 103162 103200 101920 102197 102709 103019 103072 103115 103163 103201 101923 102266 102710 103020 103073 103116 103165 103203 101925 102427 102711 103025 103074 103117 103166 103206 101929 102660 102712 103026 103075 103119 103167 103207 101932 102661 102713 103029 103076 103120 103168 103208 101933 102664 102714 103030 103077 103121 103169 103209 101934 102665 102715 103031 103078 103122 103170 103210 101937 102668 102716 103033 103080 103123 103172 103211 101945 102672 102717 103034 103081 103124 103173 103212 101947 102673 102718 103035 103082 103125 103174 103214 102149 102674 102719 103037 103083 103126 103176 103215 102150 102678 102721 103041 103084 103127 103177 103216 102153 102679 102722 103042 103085 103132 103178 103217 102154 102681 102723 103043 103087 103133 103179 103218 102155 102682 102724 103044 103088 103134 103180 103219 102156 102683 102993 103045 103089 103135 103181 103220 102159 102684 102994 103046 103091 103136 103182 103221 102161 102685 102995 103047 103092 103137 103183 103222 102162 102686 102996 103048 103094 103139 103184 103223 102163 102687 102997 103049 103095 103140 103185 103224 102164 102688 102998 103050 103096 103141 103186 103225 102167 102689 102999 103051 103097 103142 103187 103228 102168 102691 103000 103052 103098 103143 103188 103583 102172 102692 103001 103053 103099 103144 103189 103584 102173 102693 103002 103056 103100 103149 103190 103585 102176 102694 103003 103059 103101 103150 103191 103587 102178 102695 103004 103060 103102 103152 103192 103791 102183 102697 103006 103061 103103 103153 103193 103796 102184 102698 103007 103062 103104 103155 103194 103802 102185 102699 103008 103063 103108 103156 103195 103812 102187 102700 103012 103064 103109 103158 103196 103832 102189 102702 103013 103066 103110 103159 103197 103833 102190 102705 103014 103067 103111 103160 103198
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia Ow
647-999-3203
Manufacturer Reason
for Recall		There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).
FDA Determined
Cause 2		Software design
ActionAn URGENT: MEDICAL DEVICE CORRECTIVE ACTION notification letter dated 10/1/24 was sent to customers. Actions Required: Our records indicate that your facility has received one or more affected ESG-410 (SEP) units. An Olympus representative will reach out to you to coordinate a mutually convenient time to complete a software update on your affected ESG-410 (SEP) unit(s). You may continue to use your ESG-410 (SEP) generator until the software update is completed. Additionally, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. Olympus requests that you acknowledge receipt of this letter. Access the Olympus recall portal to indicate that you have received this notification. " Go to https://olympusamerica.com/recall Enter the recall number "0457 " Complete the form as instructed. 3. Olympus s record of the completed software upgrade to your ESG-410 (SEP) generator(s) will serve as the acknowledgment of this field corrective action for your facility 4. If you have further distributed this product, identify your customers, and forward them this notification. Olympus requests that you report any complaints, including the ESG-410 generator system error E1226 "Could not write to Audio Buffer , or any associated injuries to the Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail at Cynthia.Ow@Olympus.com.
Quantity in Commerce279 units
DistributionUS Nationwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GEI
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