Events

Rappel de Device Recall PKG, 5MM INSERT, RIGHT ANGLE FORCEP, 33CM

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
    69838
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0724-2015
  • Date de mise en oeuvre de l'événement
    2014-11-17
  • Date de publication de l'événement
    2014-12-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-07-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131805
  • 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
    Endoscope and/or accessories - Product Code KOG
  • Cause
    The parameters provided in the laparoscopic manual instruments instructions for use (ifu 1000-401-070 revision g or prior) do not support the unwrapped gravity cycle and the ethylene oxide cycle sterilization methods.
  • Action
    Stryker Endoscopy sent an Urgent Device Correction letter dated November 17, 2014, to affected customers. The letter informed the customers of the potential hazards and actions required. Customers were instructed to discard any old Instructions for Use for their Laparoscopic Manual Instruments and Accessories. Download the new Instuctions for Use (IFU1000-401-070 Revision J) from the URL link below: www.stryker.com/IFU1000401070 Customers were instructed to complete and sign the enclosed "Acknowledgement of Receipt" form and email them to endorecall@stryker.com or fax to (408) 855-6314. Customers with questions were instructed to contact Stryker Endoscopy at 408-855-6238 or via email at endorecall@stryker.com. For questions regarding this recall call 408-754-2000.

Device

Device Recall PKG, 5MM INSERT, RIGHT ANGLE FORCEP, 33CM
  • Modèle / numéro de série
    44493 647221 647992 745498 842129 845882 846787 847844 940092 940153 941265 941741 944824 1040124 1040628 1041467 1042526 1042527 1043031 1043779 10441058 1044108 1045039 1045371 1046186 1046395 1046955 1047068 1140260 1141156 1141790 1142614 1144485 1145002 1145148 1145969 1146672 1240949 1241420 1241798 1242459 1243202 1244181 1244438 1244527 1244594 1245525 1245545 1246645 1340475 1341523 1342388 1343130 1343554 1344027 1344278 1344686 1346102 1440693 1441635 1443223
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Description du dispositif
    PKG, 5MM INSERT, RIGHT ANGLE FORCEP, 33CM, P/N 0250080694 || Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
  • 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