Events

Recall of Device Recall MIDAS TOUCH

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Olsen Medical.

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
    36470
  • Event Risk Class
    Class 2
  • Event Number
    Z-0182-2007
  • Event Initiated Date
    2006-08-29
  • Event Date Posted
    2006-11-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48702
  • 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
    electrosurgical electrodes - Product Code JOS
  • Reason
    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
  • Model / Serial
    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.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Japan, and New Zealand.
  • Product Description
    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
  • Manufacturer Address
    Olsen Medical, 3001 W Kentucky St, Louisville KY 40211-1505
  • Source
    USFDA