Company: Olympus America Inc.
Date of Enforcement Report: 5/15/2013
Class ll:
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. Recall Number Z-1277-2013
REASON
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.
RECALLING FIRM/MANUFACTURER
Olympus America Inc., Center Valley, PA on 11/10/2009. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
608
DISTRIBUTION
Nationwide
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