Recall Z-1277-2013— Olympus America Inc.

Name: FDA recall Z-1277-2013
Creator: U.S. Food and Drug Administration
Published: 2009-11-10

Class II · Terminated

Class II FDA medical device recall by Olympus America Inc., initiated 2009-11-10, terminated 2013-07-05. It names one FDA 510(k) clearance: K030194. 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.. 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.

Recalling firm: Olympus America Inc.
Classification: Class II
Status: Terminated
Initiated: 2009-11-10
Terminated: 2013-07-05
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K030194 — XUES-41 ENDOSCOPIC ELECTROSURGICAL UNITThe Olympus Optical Co.·cleared 2003-03-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.