Events

Rappel de Device Recall GYRUS ACMI, Sterile EO

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 Medical, 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
    69226
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0100-2015
  • Date de mise en oeuvre de l'événement
    2014-08-27
  • Date de publication de l'événement
    2014-10-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-09-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129976
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Cause
    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
  • Modèle / numéro de série
    All product manufactured before July 28, 2014.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Gyrus Medical, Inc, 6655 Wedgwood Rd N Ste 160, Osseo MN 55311-3613
  • Société-mère du fabricant (2017)
    Olympus Corporation
  • Source
    USFDA