Events

Recall of Device Recall Encision AEM Suction Irrigation Electrode, LHook,

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Encision, 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
    59781
  • Event Risk Class
    Class 2
  • Event Number
    Z-3095-2011
  • Event Initiated Date
    2011-08-24
  • Event Date Posted
    2011-08-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103729
  • 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
    Electrosurgical, Cutting; Coagulation; Accessories - Product Code GEI
  • Reason
    Electrode tips have been reported breaking off during use or cleaning.
  • Action
    Encision Inc. sent out an "Urgent Product Recall" letter dated August 24, 2011 to all affected customers. The letter included: affected product, problem and instructed customers to discontinue use and return all affected electrodes to Encision. An enclosed reply form was to be faxed back to Encision indicating status of firm's inventory. For information on this recall call Encision at (303) 339-6917.

Device

Device Recall Encision AEM Suction Irrigation Electrode, LHook,
  • Model / Serial
    Catalog: REF ES3883. Lots QI, RA, and RE.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: Nationwide distribution, and the country of New Zealand.
  • Product Description
    Encision AEM Suction Irrigation Electrode, L-Hook, || REF ES3883, || Encision Inc., || Boulder, CO 80301. || The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor.
  • Manufacturer
    Encision, Inc.

Manufacturer

Encision, Inc.
  • Manufacturer Address
    Encision, Inc., 6797 Winchester Cir, Boulder CO 80301-3513
  • Manufacturer Parent Company (2017)
    Encision, Inc.
  • Source
    USFDA