Events

Recall of Gyrus ACMI Round Cutting Burrs

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Gyrus ACMI, 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
    79548
  • Event Risk Class
    Class 2
  • Event Number
    Z-1337-2018
  • Event Initiated Date
    2017-08-03
  • Event Date Posted
    2018-03-20
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162618
  • 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
    Bur, ear, nose and throat - Product Code EQJ
  • Reason
    "chattering" when cutting burrs are used in bone.
  • Action
    As a result, OSTA will issue a Field Safety Notice (FSN) to all customers that received variable exposure burrs of 5mm or greater diameter. The FSN will inform them of the concern and will advise to exercise due caution if using the affected device in proximity to sensitive or vital anatomical structures. On September 6, 2017 the firm sent a URGENT: MEDICAL DEVICE FIELD SAFETY NOTICE to the attention of the Surgical Risk Management Department for the following products: MBUR5060FRCV - Burr, 5mm Round Cutting, Variable Exposure, Standard Length, MBUR6060FRCV - Burr, 6mm Round Cutting, Variable Exposure, Standard Length and MBUR7060FRCV - Burr, 7mm Round Cutting, Variable Exposure, Standard Length for All product with an expiration date prior to August 3, 2017 Description of the problem: Olympus has become aware of an issue that requires your attention. This letter pertains to the Olympus Round Variable Cutting Burrs (Burrs) referenced above. Our records indicate that you may have purchased affected burrs. We are in receipt of a number of non-injury-related complaints that has made Olympus aware of a possibility that the burr may chatter when drilling bone. Although this chatter phenomenon can occur with any type or brand of cutting burr, depending on technique and bone density, Olympus has become aware that the larger diameter variable exposure burrs listed above can exhibit more chatter than other similar devices in some situations, particularly when they are extended to longer lengths. After extensive testing, Olympus has determined that our variable exposure burrs of less than 5mm diameter, and all fixed exposure burr offerings, are not affected by this phenomenon. Because of this, Olympus has elected to issue this field safety notice (FSN). Please refer to the enclosure with this letter that cautions of the possibility of the chatter phenomenon in the larger variable offerings. The FSN also recommends that surgeons exercise due caut

Device

Gyrus ACMI Round Cutting Burrs
  • Model / Serial
    Catalog No. (UDI-DI): MBUR5060FRCV (00821925036529), MBUR6060FRCV (00821925036536), and MBUR7060FRCV (00821925036543) ALL LOTS MANUFACTURED BEFORE AUGUST 3, 2017
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    NM, MI, and TX EU, Australia, Japan, and Hong Kong
  • Product Description
    Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
  • Manufacturer
    Gyrus ACMI, Inc.

Manufacturer

Gyrus ACMI, Inc.
  • Manufacturer Address
    Gyrus ACMI, Inc., 2925 Appling Rd, Bartlett TN 38133-3901
  • Manufacturer Parent Company (2017)
    Olympus Corporation
  • Source
    USFDA