Events

Rappel de Gyrus ACMI Round Cutting Burrs

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Gyrus ACMI, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    79548
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1337-2018
  • Date de mise en oeuvre de l'événement
    2017-08-03
  • Date de publication de l'événement
    2018-03-20
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162618
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Bur, ear, nose and throat - Product Code EQJ
  • Cause
    "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
  • Modèle / numéro de série
    Catalog No. (UDI-DI): MBUR5060FRCV (00821925036529), MBUR6060FRCV (00821925036536), and MBUR7060FRCV (00821925036543) ALL LOTS MANUFACTURED BEFORE AUGUST 3, 2017
  • Classification du dispositif
    Ear, Nose, and Throat Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    NM, MI, and TX EU, Australia, Japan, and Hong Kong
  • Description du dispositif
    Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
  • Manufacturer
    Gyrus ACMI, Inc.

Manufacturer

Gyrus ACMI, Inc.
  • Adresse du fabricant
    Gyrus ACMI, Inc., 2925 Appling Rd, Bartlett TN 38133-3901
  • Société-mère du fabricant (2017)
    Olympus Corporation
  • Source
    USFDA