Events

Rappel de Device Recall GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, 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
    65785
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1983-2013
  • Date de mise en oeuvre de l'événement
    2013-07-24
  • Date de publication de l'événement
    2013-08-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-06-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120141
  • 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
    On april 29, 2013 olympus surgical technologies america r&d; received results from an accelerated aging study conducted as part of a new market submission. the study found that one of 60 dissector units that underwent 3 year accelerated aging failed the dye penetration test indicating that the seal on sterile packaging was compromised. the dissector products are labeled with a 3 year shelf life.
  • Action
    Olympus sent a "Medical Device Recall" letter dated July 24, 2013, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customer.. Customers were advised to immediately cease any further use of the product and remove it from inventory and quarantine it until is shipped back to the company. To return the product, call 1-888-524-7266 Olympus customer service representative. Customers were requested to complete and return by fax the enclosed questionnaire to 484-896-7128. If the product was further distributed then they need to identify their customers and notify them at once of the product recall.

Device

Device Recall GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO
  • Modèle / numéro de série
    REF 3740  150080AC 258624MC G166568CC 381809KD 408020AE JF480565  NY492562  REF 3740PK 128971JB 226730IC 226742IC 226743IC 431894CE 431895CE G128677JB  REF 94201PK  102290EB 147428AC 167021CC 198596GC 204439HC 204451HC 249022KC 278142BD 320659DD 344712FD 363953ID 373761JD 389095MD 418231BE G386412KD G461037EE JF493195
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, FL, GA, IL, IN, KS,KY, MD, MA, MI, MN, MS, MO, NY, NC, OH, PA, SD, TN, TX, VA and WI., and the countries of BRAZIL, CHINA, AUSTRALIA, CHINA, GERMANY and INDIA.
  • Description du dispositif
    GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. || GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. || The Dissectors are sterile, single use electrosurgical devices that are indicated 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