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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Event Detail

Event ID 64935
Product Type Devices
Status Ongoing
Recalling Firm Olympus America Inc.
City Center Valley
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2009-11-10
Initial Firm Notification of
Consignee or Public
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Model UES-40, all serial numbers prior to 7925334 that have not been upgraded. Class II 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 some users were exceeding the maximum output time beyond the timeframes specified in the labeling. Exceeding the maximum output time can cause the UES-40 to overheat thereby causing the unit to stop working and produce smoke vapors. 608 Z-1277-2013