Events

Rappel de Device Recall MIDAS TOUCH

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 Olsen Medical.

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
    36470
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0182-2007
  • Date de mise en oeuvre de l'événement
    2006-08-29
  • Date de publication de l'événement
    2006-11-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-07-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48702
  • 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 electrodes - Product Code JOS
  • Cause
    Testing conducted by the firm indicates that electrodes identified with certain part numbers may fall out from the electrosurgical pencil or handle presenting the potential for harm or injury to the patient and/or user.
  • Action
    The firm issued an ''Urgent: Device Recall'' notification to their customers via letter and E-mail on 8/29/2006 and 8/30/2006. The letter informs the customers of this problem and asks that the customers contact their sub-accounts and notify them of the problem if they have further distributed any of the suspect part numbers. The letter also asks that the distributor/customer(s) have the subaccounts discontinue use of the product; and return the held product to the distributor (who in turn, should return the product to Olsen Medical for reimbursement). The customers are asked to complete and fax back to the recalling firm, an attached Acknowledgement form documenting receipt of the recall notification by the customer/employee with name and date received. The firm also asked that the customer supply information regarding the amount of inventory /shipped on a checklist. The amounts received are broken down on the Checklist by Lot Number with the amount of product in inventory and the amount of product shipped. These amounts are reported by the responders by ''pieces and cases'' on hand at the time that the notice was received.

Device

Device Recall MIDAS TOUCH
  • Modèle / numéro de série
    4 inch Standard Electrodes - Model Number: 30-0002, Lot Numbers: 110201, 116228, 117331, 117985, 120959 and 000501; and 4 inch Modified Electrodes - Part Number: 30-0012, Lot Numbers: 110101, 113523, 113877, 114428, 114527, 115294, 115420, 119874, 120223, 120732 and 120883.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, including USA, Japan, and New Zealand.
  • Description du dispositif
    MIDAS TOUCH Electrosurgical/102 mm (4 inch) Blade Electrodes, Disposable, Sterile Single Use Device, Part #30-0012 and #30-0002. The electrodes are individually packaged in Tyvek bags with 12 packages per case.
  • Manufacturer
    Olsen Medical

Manufacturer

Olsen Medical
  • Adresse du fabricant
    Olsen Medical, 3001 W Kentucky St, Louisville KY 40211-1505
  • Source
    USFDA