BEUDAMED
    FDA Recall Terminated

    PEAK brand PlasmaBlade EXT, Tissue Dissection Device, Catalogue Number: PS215-040; Product is manufactured and distributed by PEAK Surgical, Palo Alto, CA The PEAK Surgery System is indicated for the cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopedic, Arthroscopic, Spinal and Neurological procedures.

    Recall: Z-1022-2011 · Initiated May 19, 2009

    Recall

    Recall Number
    Z-1022-2011
    Event Number
    53014
    Firm
    Peak Surgical
    FEI Number
    3007069406
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 19, 2009
    Posted
    February 2, 2011
    Terminated
    April 21, 2011
    Address
    2464 Embarcadero Way, Palo Alto, CA, 94303-3313

    Description

    PEAK brand PlasmaBlade EXT, Tissue Dissection Device, Catalogue Number: PS215-040; Product is manufactured and distributed by PEAK Surgical, Palo Alto, CA The PEAK Surgery System is indicated for the cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopedic, Arthroscopic, Spinal and Neurological procedures.

    Reason

    A customer reported that a patient suffered a burn while using the device.

    Action

    Peak Surgical notified afftected customers by phone on May 19, 2009. They were notified of the product, the problem, and the action to be taken. Peak Surgical sales representatives removed PlasmaBlade EXT devices from consignees affected by the recall.

    Distribution

    Worldwide Distribution - United States including CA, CO, FL, IL, MD, MN, NV, NY, OH, OK, TN, TX, UT, and WAand the countries of Turkey and Ireland

    Quantity

    493 units