Events

Recall of Device Recall Olympus SurgMaster UES40 electrosurgical unit ("UES40")

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Olympus America Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64935
  • Event Risk Class
    Class 2
  • Event Number
    Z-1277-2013
  • Event Initiated Date
    2009-11-10
  • Event Date Posted
    2013-05-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117456
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
  • 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.
  • 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.

Device

Device Recall Olympus SurgMaster UES40 electrosurgical unit ("UES40")
  • Model / Serial
    Model UES-40, all serial numbers prior to 7925334 that have not been upgraded.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 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.
  • Manufacturer
    Olympus America Inc.

Manufacturer

Olympus America Inc.
  • Manufacturer Address
    Olympus America Inc., 3500 Corporate Pkwy., P.O. Box 610, Center Valley PA 18034-0610
  • Manufacturer Parent Company (2017)
    Olympus Corporation
  • Source
    USFDA