Events

Rappel de Device Recall GYRUS ACMI PKS PlasmaSEAL Open Forceps

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 Gyrus Medical, 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
    35477
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1175-06
  • Date de mise en oeuvre de l'événement
    2006-05-15
  • Date de publication de l'événement
    2006-06-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-01-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46199
  • 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
    Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
  • Cause
    Gyrus acmi has identified a product issue wherein their plasmaseal open forceps, models 2103pk and 917015pk, may not deliver adequate hemostasis during use. although gyrus acmi has had no reports of serious injury to patient, testing indicated that the possibility exists.
  • Action
    US accounts were initially contacted by phone beginning 05/15/2006 and then sent a follow-up letter sent 05/31/2006. Customers were told of the issue, instructed to discontinue use of the product, told to remove all 2103PK and 917015PK devices from shelves and to quarantine product until they receive a letter with instructions to return the affected devices to Gyrus ACMI.

Device

Device Recall GYRUS ACMI PKS PlasmaSEAL Open Forceps
  • Modèle / numéro de série
    Catalog No. 2103PK and 917015PK all production codes
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Australia, Canada, Netherlands. (AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, VA, WA, WI, WV).
  • Description du dispositif
    GYRUS ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.93 or greater or the PlasmaKinetic with SuperPulse electrosurgical generator, software version 2.19A or greater or the G400 electrosurgical generator. Made in USA Gyrus ACMI, Gyrus Medical, Inc., 6655 Wedgwood Road, Suite 160, Maple Grove, MN 55311-3602.
  • Manufacturer
    Gyrus Medical, Inc.

Manufacturer

Gyrus Medical, Inc.
  • Adresse du fabricant
    Gyrus Medical, Inc., 6655 Wedgewood Road, Suite 105, Maple Grove MN 55311
  • Source
    USFDA