Events

Rappel de Device Recall NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe

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 Monteris Medical Corp.

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
    73849
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1614-2016
  • Date de mise en oeuvre de l'événement
    2016-03-25
  • Date de publication de l'événement
    2016-05-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145141
  • 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
    Powered laser surgical instrument - Product Code GEX
  • Cause
    Monteris received a report that the sapphire lens on a 2.2sf probe fractured during a litt procedure, with resulting introduction of c02 into the patient's brain.
  • Action
    Monteris Medical Corporation field personnel visited each consignee starting March 25, 2016 and April 1, 2016. The devices were physically removed from each site. Customers from whom the devices were removed will either receive a credit or receive replacements of other models of laser delivery probes.

Device

Device Recall NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe
  • Modèle / numéro de série
    All unexpired lots of these models are being removed from the market.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution in the states of KS, MO, NC, OH, and VA.
  • Description du dispositif
    NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01, SFS222-01, SFS322-01, SFS422-01, and SFS522-01. || NeuroBlate System SideFire Select Directional Laser Probes are part of the NeuroBlate System. The Monteris Medical NeuroBlate System is indicated for use to ablate, necrotize, or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers. The Monteris Medical NeuroBlate System is intended for planning and monitoring thermal therapies under MRI visualization. It also provides real-time thermographic analysis of selected MRI images. The laser delivery probes direct the laser energy to the proper treatment location.
  • Manufacturer
    Monteris Medical Corp

Manufacturer

Monteris Medical Corp
  • Adresse du fabricant
    Monteris Medical Corp, 16305 36th Ave N Suite 200, Plymouth MN 55446-2884
  • Société-mère du fabricant (2017)
    Monteris Medical Corp
  • Source
    USFDA