BEUDAMED
    FDA Enforcement Class II Terminated

    GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.

    Recall: Z-1983-2013 · Reported August 28, 2013

    Enforcement

    Recall Number
    Z-1983-2013
    Event ID
    65785
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Gyrus Medical, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 28, 2013
    Initiation Date
    July 24, 2013
    Classification Date
    August 19, 2013
    Termination Date
    June 20, 2014
    Address
    6655 Wedgwood Rd N Ste 160, N/A, Osseo, MN, 55311-3613, United States

    Description

    GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.

    Reason

    On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study conducted as part of a new market submission. The study found that one of 60 Dissector units that underwent 3 year accelerated aging failed the dye penetration test indicating that the seal on sterile packaging was compromised. The dissector products are labeled with a 3 year shelf life.

    Code Info

    REF 3740 150080AC 258624MC G166568CC 381809KD 408020AE JF480565 NY492562 REF 3740PK 128971JB 226730IC 226742IC 226743IC 431894CE 431895CE G128677JB REF 94201PK 102290EB 147428AC 167021CC 198596GC 204439HC 204451HC 249022KC 278142BD 320659DD 344712FD 363953ID 373761JD 389095MD 418231BE G386412KD G461037EE JF493195

    Distribution

    Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, FL, GA, IL, IN, KS,KY, MD, MA, MI, MN, MS, MO, NY, NC, OH, PA, SD, TN, TX, VA and WI., and the countries of BRAZIL, CHINA, AUSTRALIA, CHINA, GERMANY and INDIA.

    Quantity

    1140