BEUDAMED
    FDA Enforcement Class II Terminated

    PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a neutral plasma surgery system that is designed for cutting and coagulation in open surgery and laparoscopic surgery.

    Recall: Z-1794-2012 · Reported June 20, 2012

    Enforcement

    Recall Number
    Z-1794-2012
    Event ID
    61951
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Plasma Surgical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 20, 2012
    Initiation Date
    April 27, 2012
    Classification Date
    June 11, 2012
    Termination Date
    November 1, 2012
    Address
    1009 Mansell Rd Ste F, Roswell, GA, 30076-4806, United States

    Description

    PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a neutral plasma surgery system that is designed for cutting and coagulation in open surgery and laparoscopic surgery.

    Reason

    Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible leakage of a very small drop of distilled water coolant from the handpiece in use.

    Code Info

    Lot Number 40041, exp. date February 2015 and Lot Number 40043, exp. date February 2015

    Distribution

    Worldwide distribution: USA (nationwide) including states of: CA and NY; and country of: United Kingdom.

    Quantity

    36 units