  |
Lumenis VersaCut Tissue Morcellator: Class 1 Recall - Labeling Correction - Potential For Air Embolisms To Occur If Tubing Is Hooked Up Backwards
AUDIENCE: Biomedical Engineering, Risk Managers, Surgery
ISSUE: Lumenis Limited is recalling certain models of VersaCut Morcellator devices to correct its labeling. There is a potential for air embolisms to occur if the aspiration tubing is hooked up backwards to the aspiration control box housing. This product may cause serious adverse health consequences, including death.
BACKGROUND: These devices break up and remove dissected tissue during surgical procedures when access to the surgical site is limited.
RECOMMENDATION: Lumenis placed an immediate internal quarantine on all affected products within its possession. The firm will re-label these devices and replace the current Operator's Manual with the revised Manual. On Jan. 2, 2013, Lumenis sent an Urgent Safety Advisory Notice letter to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to re-label the device with the two labels provided, remove and destroy the existing Operator’s Manual and replace it with the current revised Manual, complete the information requested on the confirmation card provided and return the confirmation card using the enclosed, pre-paid UPS shipping label. The firm will send follow-up notices to customers who do not respond in 30, 60, and 90 days.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Class I Recall Notice, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
