BEUDAMED
    FDA Recall Terminated

    Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.

    Recall: Z-2770-2015 · Initiated July 30, 2015

    Recall

    Recall Number
    Z-2770-2015
    Event Number
    71851
    Firm
    Lumenis 13 Hayetzira St., Yokneam Ind. Park Yokneam Israel
    FEI Number
    3004135191
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 30, 2015
    Posted
    September 16, 2015
    Terminated
    May 25, 2018

    Description

    Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.

    Reason

    There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation procedure resulting in damage to non-target tissue.

    Action

    Lumenis sent an Urgent Medical Device Recall letter on August 7, 2015, to all consignees. Consignees were instructed to destroy the operator manual, and return the affected device to Lumenis along with the completed Recall Verification form. Consignees with questions were instructed to call 801-656-2663.

    Distribution

    Worldwide Distribution - US including CA, PA, MA, FL, and NY, and Internationally to Italy, Germany, Australia, China, Great Britian, United Kingdom, Taiwan, France, Peru, Mexico, Turkey, Spain, and Russia.

    Quantity

    54 devices with 108 hand pieces