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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus SurgMaster UES40 electrosurgical unit ("UES40")

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  Class 2 Device Recall Olympus SurgMaster UES40 electrosurgical unit ("UES40") see related information
Date Initiated by Firm November 10, 2009
Date Posted May 08, 2013
Recall Status1 Terminated 3 on July 05, 2013
Recall Number Z-1277-2013
Recall Event ID 64935
510(K)Number K030194  
Product Classification Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
Product Olympus SurgMaster UES-40 electrosurgical unit ("UES-40")

Product Usage: Designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) and endoscopic surgery including urology, gynecology, respiratory and gastroenterology in conjunction with Olympus designed electrosurgical accessories, endoscopes (fiberscopes, videoscopes and rigid scopes) applicable for electrosurgery (cutting and coagulation), light sources and other ancillary equipment.
Code Information Model UES-40, all serial numbers prior to 7925334 that have not been upgraded.
Recalling Firm/
Manufacturer		 Olympus America Inc.
3500 Corporate Pkwy.
P.O. Box 610
Center Valley PA 18034-0610
For Additional Information Contact
484-896-5688
Manufacturer Reason
for Recall		 Olympus initiated a software upgrade and enhancement in 2009 and completed the action in 2010. The upgrade and enhancement were initiated due to complaints of overheating, smoke vapors and failure to operate associated with the Olympus SurgMaster electrosurgical unit, model UES-40 ("UES-40") when used in conjunction with the Olympus WA22557C electrode. The complaint investigations revealed that
FDA Determined
Cause 2		 Use error
Action Olympus America Inc sent a Field Corrective Action letter dated November 10, 2009 to all affected consignees. The letter identified the affected product, problem and actions to be taked. Consignees were directed to contact Gyrus at 888-524-7266 to schedule return of the UES-40 generator for the software upgrade. The letter also directed consignees to contact OAI Customer Service at 800-848-9024 if they needed a new copy of the UES-40 Instruction Manual. For questions call 484-896-5688.
Quantity in Commerce 608
Distribution Nationwide Distribution - USA Nationwide including the states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, and WY.
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KNS and Original Applicant = THE OLYMPUS OPTICAL CO.
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