The Recall Desk
HighFDA (Devices)·Z-1277-2013·Announced 2013-05-15

Olympus UES-40 Electrosurgical Unit Recalled for Overheating and Smoke

Olympus America Inc. is recalling 608 UES-40 electrosurgical units due to overheating, smoke vapors, and operational failures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device with reported hazards of overheating and smoke vapors, which pose a risk of harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Olympus America Inc. is recalling 608 units of the Olympus SurgMaster UES-40 electrosurgical unit. The recall covers all serial numbers prior to 7925334 that have not been upgraded. These devices are designed for use in medical facilities under the supervision of a trained physician for general and endoscopic surgery.

The recall was initiated following complaints of overheating, smoke vapors, and failure to operate when the UES-40 was used in conjunction with the Olympus WA22557C electrode. Investigations into these complaints revealed issues that led to the initiation of a software upgrade and enhancement in 2009, which was completed in 2010.

The affected units were distributed nationwide in the United States. Medical facilities should stop using the affected units and contact Olympus America Inc. for further instructions regarding the software upgrade or replacement.

The recalled product

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 gastroen
Affected units
608

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Model UES-40
  • all serial numbers prior to 7925334 that have not been upgraded.

Distribution

Distributed nationwide across the United States.

The notice also names 41 states specifically: