Events

Recall of Device Recall GYRUS ACMI, Sterile EO

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
    69226
  • Event Risk Class
    Class 2
  • Event Number
    Z-0100-2015
  • Event Initiated Date
    2014-08-27
  • Event Date Posted
    2014-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129976
  • 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
    Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product.
  • Action
    Olympus sent a Medical Device Recall letter dated August 26, 2014, via FEDEX to all affected consignees. The letter described the issue and the product involved in the recall. It also described the action that the consignee needs to take. Consignees were instructed to cease further use of the device, quarantine it and return it to the manufacturer.Consigness were instructed to complete and return by fax (484-896-7128) the questionnaire enclosed. If the product was further distributed consignees should notify their customers of the product recall. For additional information they can call 484-896-5688. For questions regarding this recall call 484-896-5688.

Device

Device Recall GYRUS ACMI, Sterile EO
  • Model / Serial
    All product manufactured before July 28, 2014.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including US: AL, AZ, CA, FL, GA, HI, IL, IN, IA, KY, MA,MI,MS, NJ, NY, NC, OH, PA, SC, TN, UT, and WA. Internationally to ITALY, SPAIN, UNITED KINGDOM, and CHINA.
  • Product Description
    GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm || REF 3345PK - PKS MOLly Forceps 5mm/45cm || REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm || REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm || REF 3844- Everest BiCOAG LP Scissors 5mm/45cm || REF 910010PK- PKS MOLly Forceps 5mm/45cm || Single-use, sterile devices intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.
  • Manufacturer
    Gyrus Medical, Inc

Manufacturer

Gyrus Medical, Inc
  • Manufacturer Address
    Gyrus Medical, Inc, 6655 Wedgwood Rd N Ste 160, Osseo MN 55311-3613
  • Manufacturer Parent Company (2017)
    Olympus Corporation
  • Source
    USFDA