Events

Recall of Device Recall Endoscope Clip applier, Implantable Fastener and Accessories

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Endogastric Solutions 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
    64395
  • Event Risk Class
    Class 2
  • Event Number
    Z-1136-2013
  • Event Initiated Date
    2013-02-04
  • Event Date Posted
    2013-04-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116023
  • 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
    Endoscopic suture/plication system, gastroesophageal reflux disease (gerd) - Product Code ODE
  • Reason
    Esophyx2plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.
  • Action
    EndoGastric Solutions, Inc. sent an Urgent Medical Device Recall letter dated January 31, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to segregate and record lot numbers for any affected product. If no product remain in inventory customers were instructed to report such to customer service. Upon receipt of the product a credit will be issued for each device returned. For any questions customers were instructed to call 425-307-9226. For questions regarding this recall call 425-307-9200.

Device

Device Recall Endoscope Clip applier, Implantable Fastener and Accessories
  • Model / Serial
    Lots 401378, 401392, 401409, and 401416 Additional lots manufactured from 11/26/12 to 12/07/12 had a stop ship issued issued on 11/21/12 and the product was placed in quarantine (it was not distributed). This represents an additional 175 units from a total of 187 units manufactured during this time period. 12 units were used for bench testing. The lot numbers of units in quarantine are 401432, 401434, 401436, and 401441.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including NC, VA, WI, TN, KY, IN, FL, MI, IA, IL, TX, LA, AR, HI, CA, NV, OR, and WA,
  • Product Description
    EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in part "EsophyX2 2-LINK Device Qty: (1) Fastener Delivery System ***" || Designed for the treatment of Gastroesophageal Reflux Disease (GERD), with erosive and non-erosive esophagitis
  • Manufacturer
    Endogastric Solutions Inc

Manufacturer

Endogastric Solutions Inc
  • Manufacturer Address
    Endogastric Solutions Inc, 8210 154th Ave NE, Redmond WA 98052-3877
  • Manufacturer Parent Company (2017)
    Endogastric Solutions Inc
  • Source
    USFDA