Emerging NeuroBlate Probe Litigation
The NeuroBlate probe made by Moneris Medical, Inc. is a device used during various types of complex neurological surgeries.
March 2018 FDA Communication Excerpt:
ISSUE: The FDA is providing preliminary information about the potential for unintended heating and patient injury with use of the Monteris Medical NeuroBlate probe, which is part of the NeuroBlate System, and bringing to your attention a Class I recall for the device.
A Class I recall is the most serious type of recall and is issued when use of the device may cause serious injuries or death. Monteris issued three product advisories between October and December 2017, which were part of the Class I recall; however, the FDA has concerns that the information provided by Monteris has not sufficiently mitigated the risk of unintended probe tip heating. We are working with the manufacturer to address these concerns.
The device is currently the subject of a voluntary recall which was initiated by the firm, and classified as a Class I Recall by the FDA, due to several instances of unintended heating and damage to the probe, which may have resulted in unintended damage to surrounding brain tissue. The damage to the probe appears to have been caused by an interaction between the thermocouple in the probe, and the MRI environment. These events occurred independent of laser energy delivery, and have been associated with damage to the tip of the probe implanted within the brain (e.g., charring, release of carbon dioxide).
To Learn More About the Emerging NeuroBlate Probe Litigation:
The Emerging Moneris Medical NeuroBlate Probe Litigation will be used as a case study in the May 18 – 21, 2018 Mass Tort Nexus, “Four Days to Mass Tort Success Course” To register for the May Course, contact Jenny Levine at email@example.com or call (954) 520-4494.
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