Events

Rappel de Device Recall PneumoSure

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 Stryker Endoscopy.

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
    73674
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1566-2016
  • Date de mise en oeuvre de l'événement
    2016-03-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144721
  • 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
    Insufflator, laparoscopic - Product Code HIF
  • Cause
    When operating the device in high flow mode (40l/min, 15 mmhg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0l/min and the red check gas supply symbol would appear on the display, immediately suspending insufflation.
  • Action
    Urgent Medical Device Recall letters were sent to domestic customers on March 28, 2016 by certified mail. Stryker International distribution sites were notified and are responsible for providing information to affected customers.

Device

Device Recall PneumoSure
  • Modèle / numéro de série
    HPUs affected lot numbers 0005051337-000505052795; PneumoSure insufflators affected serial numbers 1510CE0342-1601CE0581
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution. US nationwide including Puerto Rico, China, Hong Kong, India, Japan, Korea, Romania, Vietnam, Singapore, Taiwan, Netherlands, Peru, Australia, Canada, Mexico, Argentina, Chile, Poland, South Africa, and Guatemala.
  • Description du dispositif
    PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; || High pressure units (HPU) (40L and 45L). || Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 620-040-601, 620-040-602, 620-040-604, 105-210-684 || The Pneumo Sure XL High Flow Insufflator is a device that serves to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy. The insufflator consists of a console, that is intended to be connected to a CO2 gas source, and has a tubeset inserted to transport CO2 gas from the insufflator to the connecting trocar.
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • Adresse du fabricant
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA