Events

Rappel de Device Recall Olympus SurgMaster UES40 electrosurgical unit ("UES40")

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Olympus America Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    64935
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1277-2013
  • Date de mise en oeuvre de l'événement
    2009-11-10
  • Date de publication de l'événement
    2013-05-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117456
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
  • Cause
    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")
  • Modèle / numéro de série
    Model UES-40, all serial numbers prior to 7925334 that have not been upgraded.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Olympus America Inc., 3500 Corporate Pkwy., P.O. Box 610, Center Valley PA 18034-0610
  • Société-mère du fabricant (2017)
    Olympus Corporation
  • Source
    USFDA