BEUDAMED
    FDA Enforcement Class III 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 · Reported October 10, 2018

    Enforcement

    Recall Number
    Z-0062-2019
    Event ID
    80970
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Dannoritzer Medizintechnik GmbH & Co. KG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 10, 2018
    Initiation Date
    August 6, 2018
    Classification Date
    October 3, 2018
    Termination Date
    July 22, 2019
    Address
    Sattlerstr. 25, Tuttlingen, N/A, Germany

    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.

    Code Info

    none

    Distribution

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