BEUDAMED
    FDA Recall Terminated

    Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulation

    Recall: Z-0062-2019 · Initiated August 6, 2018

    Recall

    Recall Number
    Z-0062-2019
    Event Number
    80970
    Firm
    Dannoritzer Medizintechnik GmbH & Co. KG Sattlerstr. 25 Tuttlingen Germany
    FEI Number
    1000482681
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    August 6, 2018
    Terminated
    July 22, 2019

    Description

    Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulation

    Reason

    The Manual cleaning process and the usability of the reprocessing instruction by the user had not been validated. The IFU was modified to remove the manual cleaning method and revised the instructions for use for clarity and readability.

    Action

    In July 2017, Dannoritzer Medizintechnik GmbH & Co. KG issued emails to customers notifying them that an updated Instructions For Use (IFU) manual would be distributed by July 27, 2018. On August 8, 2018, Dannoritzer Medizintechnik GmbH & Co. KG issued Urgent Medical Device Field Correction notices dated August 6, 2018 to customers along with an updated IFU. Customers were encouraged to immediately remove from their place of use and destroy the existing original DANmed Laparoscopy Instruments IFU as well as any copies and replace them with the revised version (V.2018-08-03) included with the notice. Distributors or those who have further distributed the product, please provide those customers with a copy of the notice and revised IFU. Customers are also encouraged to complete and return the Confirmation Card and email to [email protected] Customers with questions may contact Stefan Rauch 011-49-7461-9623915 8 am - 12 PM, EST or email [email protected]

    Distribution

    US Nationwide in the States of OH, MI, MA, CA, OK, TN, GA, FL, IL, NC, TX, MO.