Events

Recall of Device Recall GYRUS ACMI PKS PlasmaSEAL Open Forceps

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Gyrus Medical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    35477
  • Event Risk Class
    Class 2
  • Event Number
    Z-1175-06
  • Event Initiated Date
    2006-05-15
  • Event Date Posted
    2006-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46199
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
  • Reason
    Gyrus acmi has identified a product issue wherein their plasmaseal open forceps, models 2103pk and 917015pk, may not deliver adequate hemostasis during use. although gyrus acmi has had no reports of serious injury to patient, testing indicated that the possibility exists.
  • Action
    US accounts were initially contacted by phone beginning 05/15/2006 and then sent a follow-up letter sent 05/31/2006. Customers were told of the issue, instructed to discontinue use of the product, told to remove all 2103PK and 917015PK devices from shelves and to quarantine product until they receive a letter with instructions to return the affected devices to Gyrus ACMI.

Device

Device Recall GYRUS ACMI PKS PlasmaSEAL Open Forceps
  • Model / Serial
    Catalog No. 2103PK and 917015PK all production codes
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Canada, Netherlands. (AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, VA, WA, WI, WV).
  • Product Description
    GYRUS ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.93 or greater or the PlasmaKinetic with SuperPulse electrosurgical generator, software version 2.19A or greater or the G400 electrosurgical generator. Made in USA Gyrus ACMI, Gyrus Medical, Inc., 6655 Wedgwood Road, Suite 160, Maple Grove, MN 55311-3602.
  • Manufacturer
    Gyrus Medical, Inc.

Manufacturer

Gyrus Medical, Inc.
  • Manufacturer Address
    Gyrus Medical, Inc., 6655 Wedgewood Road, Suite 105, Maple Grove MN 55311
  • Source
    USFDA