15

May

2013

Olympus SurgMaster UES-40 Cl ll

0

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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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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