Events

Rappel de Endopath Electrosurgery Probe Plus II

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 Ethicon Endo-Surgery 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
    65504
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1772-2013
  • Date de mise en oeuvre de l'événement
    2013-04-08
  • Date de publication de l'événement
    2013-07-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-12-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119518
  • 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
    Laparoscope, general; plastic surgery - Product Code GCJ
  • Cause
    The firm is recalling the endopath probe plus ii shafts because the possibility that a tear in the tyvek packaging may affect the sterility of the device.
  • Action
    The firm, Ethicon Endo-Surgery, Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated April 22, 2013 to all consignees/customers via overnight UPS to allow tracking of the receipt. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to do the following: EFFECTIVE IMMEDIATELY-DO NOT USE ANY OF THE FOLLOWING TWELVE (12) PRODUCT CODES within the noted Expiration Dates provide in the letter; examine your inventory immediately to determine if you have affected product on hand; remove the affected product; complete and return the Business Reply Form (BRF) and fax to: 1-888-912-7089 or email to: ees3118@stericycle.com within 3 business days, even if you do not have affected product; return affected product with a photocopy of the completed BRF; and share this information with all of the appropriate staff at your facility. If you need additional shipping labels or a communications package, contact the Stericycle's support center at 1-888-943-4896 and reference Event 3118. "Returned ENDOPATH Probe Plus II Shafts will be replaced with corrected ENDOPATH Probe Plus II Shafts once supply becomes available. If replacement product is not available and/or has been discontinued, a credit will be issue." If you need clinical or product support, please contact your local representative or call our Customer Support Center, 1-877-ETHICON (877-384-4266).

Device

Endopath Electrosurgery Probe Plus II
  • Modèle / numéro de série
    Product Code: EPS01, Exp. Date: 2015 09 through 2018 03; Product Code: EPS02, Exp. Date: 2015 09 through 2018 03; Product Code: EPS03, Exp. Date: 2015 09 through 2018 03; Product Code: EPS04, Exp. Date: 2015 09 through 2018 03; Product Code: EPS05, Exp. Date: 2015 09 through 2018 03; Product Code: EPS06, Exp. Date: 2015 09 through 2018 03; Product Code: EPS07, Exp. Date: 2015 09 through 2018 03; Product Code: EPS08, Exp. Date: 2015 09 through 2018 03; Product Code: EPS10, Exp. Date: 2013 04 through 2018 03; Product Code: EPS11, Exp. Date: 2013 04 through 2018 03; Product Code: EPS12, Exp. Date: 2013 04 through 2018 03 & Product Code: EPS13, Exp. Date: 2013 04 through 2018 03.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, lA, ID, IL, IN, KS, KY, LA, MA, MD, ME, Ml, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY and countries of: Canada, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Dominican Republic, Ecuador, Egypt, India, Indonesia, Israel, Italy, Jamaica, Japan, Korea, Kuwait, Libya, Malaysia, Mexico, Pakistan, Panama, Philippines, Poland, Puerto Rico, Russia, Singapore, Slovenia, South Africa, Spain, Saudi Arabia, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, & Venezuela.
  • Description du dispositif
    Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and stone retrieval cannula, packaged and sterilized individually in a transparent flexible blister sealed to a Tyvek lid. 6 flexible packages are placed into a sales unit carton, with 4 cartons per corrugated shipper. || The Endopath Electrosurgery Probe Plus II system has application in minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation through a common trocar sleeve.
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

Ethicon Endo-Surgery Inc
  • Adresse du fabricant
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA