BEUDAMED
    FDA Enforcement Class II Terminated

    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

    Recall: Z-2727-2014 · Reported October 8, 2014

    Enforcement

    Recall Number
    Z-2727-2014
    Event ID
    68725
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Instrumed International, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 8, 2014
    Initiation Date
    May 30, 2014
    Classification Date
    September 30, 2014
    Termination Date
    November 29, 2017
    Address
    626 Cooper Ct, N/A, Schaumburg, IL, 60173-4537, United States

    Description

    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

    Reason

    Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.

    Code Info

    1) Instrumed Item No.: 250-08860; Symmetry Surgical Inc. Catalog Code: 90-9525; Lot Number: 030214; 2) Instrumed Item No.: 250-08930; Symmetry Surgical Inc. Catalog Code: 90-9522; Lot Number: 070511; 3) Instrumed Item No.: 250-08990; Symmetry Surgical Inc. Catalog Code: 90-9526; Lot Number: 031511; 4) Instrumed Item No.: 250-09010; Symmetry Surgical Inc. Catalog Code: 90-9523; Lot Number: 080112

    Distribution

    Distribution US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.

    Quantity

    895 instruments