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Safety Alert

URGENT – MEDICAL DEVICE SAFETY ALERT

June 26, 2009

Dear Valued Customer:

It has come to our attention that a customer has reported pieces of tissue remaining within Smith & Nephew Shaver Motor Drive Unit (Handpiece) after the cleaning process had been completed prior to sterilization. All personnel responsible for device cleaning and sterilization at your facility must be aware of and fully compliant with the following instructions, extracted from our current Instructions For Use for the Handpiece:

1. It is critical to observe the prescribed cleaning directions to thoroughly clean the devices.

2. As stated in Step 6 of the instructions, scrub all internal surfaces or holes with a tight-fitting brush using a twisting action. The brush should be of an appropriate size to ensure that the full depth of the area is reached.

Additional Information: If you have questions regarding this notice, please contact Smith & Nephew Endoscopy’s Technical Support at 800.343.5717 Option 2, between the hours of 8AM and 6PM EST.

Additional tips and recommendations for cleaning procedures including decontamination and sterilization of Smith & Nephew Endoscopy devices can be found on our website using the following link:

http://global.smith-nephew.com/cps/rde/xbcr/smithnephewls/DecontandSterilEndo10600015.pdf

Events can be reported directly to the FDA through the MedWatch program by phone (1-800-FDA-1088) or by the Internet at http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

Sincerely,

Nigel Wilkinson
Senior Vice President, Regulatory Affairs & Quality
Smith & Nephew Endoscopy