BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1614-2016 · Initiated March 25, 2016

    Recall

    Recall Number
    Z-1614-2016
    Event Number
    73849
    Firm
    Monteris Medical Corp
    FEI Number
    3009970070
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 25, 2016
    Posted
    May 16, 2016
    Terminated
    March 10, 2017
    Address
    16305 36th Ave N, Suite 200, Plymouth, MN, 55446-2884

    Description

    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.

    Reason

    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.

    Distribution

    Nationwide Distribution in the states of KS, MO, NC, OH, and VA.

    Quantity

    121