Events

Rappel de Device Recall Endoscope Clip applier, Implantable Fastener and Accessories

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 Endogastric Solutions 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
    64395
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1136-2013
  • Date de mise en oeuvre de l'événement
    2013-02-04
  • Date de publication de l'événement
    2013-04-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116023
  • 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
    Endoscopic suture/plication system, gastroesophageal reflux disease (gerd) - Product Code ODE
  • Cause
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including NC, VA, WI, TN, KY, IN, FL, MI, IA, IL, TX, LA, AR, HI, CA, NV, OR, and WA,
  • Description du dispositif
    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
  • Adresse du fabricant
    Endogastric Solutions Inc, 8210 154th Ave NE, Redmond WA 98052-3877
  • Société-mère du fabricant (2017)
    Endogastric Solutions Inc
  • Source
    USFDA