Z-1277-2013Class II

Olympus SurgMaster UES-40 electrosurgical unit ("UES-40")

Name: Z-1277-2013 Olympus SurgMaster UES-40 electrosurgical unit ("UES-40")
Creator: Olympus America Inc.
Published: 2009-11-10
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2009-11-10 / Terminated / root cause: software

FDA source

Olympus America Inc. began a recall of Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for use in a medical facility under the supervision of a trained physician... on 2009-11-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1277-2013
Classification: Class II
Status: Terminated
Initiated: 2009-11-10
Posted: 2013-05-08
Terminated: 2013-07-05
Recalling firm: OLYMPUS Corporation of the Americas
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.
Product code: KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
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
Root cause tag: software
FDA root cause: 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.
Product codes and lots: Model UES-40, all serial numbers prior to 7925334 that have not been upgraded.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1277-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1277-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-08

Product code KNS

K030194Class IIXues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. / cleared 2003-03-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)