Class 2 Device Recall VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM

• Date Initiated by Firm: January 10, 2011
• Date Posted: February 14, 2011
• Recall Status: Terminated on July 13, 2011
• Recall Number: Z-1230-2011
• Recall Event ID: 57735
• 510(K)Number: K083194
• Product Classification: Laparoscope, general &38; plastic surgery - Product Code GCJ
• Product: Bipolar cord for use with the VirtuoSaph Endoscopic Vein Harvesting System, MCBICORD1, Terumo Cardiovascular System, Ann Arbor, MI.; The Terumo Bipolar cord MCBICORD1 is a flexible, reusable power cable that is indicated for use with the Terumo VirtuoSaph Endoscopic Vein Harvesting System and a compatible generator during saphenous vein harvesting procedures.
• Code Information: 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 4ZK, 51K, 52K, 53K, 54K, 55K, 6XK, 6ZK, 71K, 72K, 73K, 74K, 75K, 76K, 77K, 78K, 79K, 7XK, 7YK, 7ZK, 81K, 82K, 83K, 84K, 85K, 86K, 87K, 87K, 88K, 89K, 8XK, 8YK, 8ZK, 91K, 95K, 96K, 97K, 99K, 9XK, 9YK and 9ZK.
• Recalling Firm/ Manufacturer: Terumo Cardiovascular Systems Corporation; 6200 Jackson Road; Ann Arbor MI 48103-9586
• For Additional Information Contact: 734-741-6173
• Manufacturer Reason for Recall: The Bipolar cord product specification indicates the product has a service life of 50 uses. However the IFU does not specify an end of service life. The firm has recieved 46 complaints on the Bipolar cord. The firm investigated and found that the units involved in the complaints were often over 12 months old. The firm believes the units involved in the complaints were beyond their product life
• FDA Determined Cause: Other
• Action: Terumo Cardiovascular Systems Corporation sent an URGENT MEDICAL DEVICE CORRECTION letter dated January 10, 2011, to Operating room managers. The letter informed the customers of the Bipolar cord product life of 50 uses. The letter states that the IFU for the bipolar cord is being updated to include the information regarding the limit of 50 uses and sterlization cycles. The letter recommends that user keep a sterile back up bi-polar cord in a convienent place during endoscopic vein harvesting procedures. The firm provided a tracking sheet in each package to help users track the number of sterlization cycles for the cord. Customers were instructed to review the Medical Device Correction notice, assure that all users were aware of the notice, and confirm receipt of the communicaiton by faxing the attached Customer Response Form to the fax number indicated on the form. For questions regarding this recall call Terumo CVS Customer Service at 1-800-521-2818.
• Quantity in Commerce: 2782 cords
• Distribution: Worldwide Distribution - United States including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, , NY, MO, MS, MT, NC, NE, NH, NJ, NM, OH, OK, OR, PA, SC, TN, TX, VA, WI, AND WV and the countries of Chile, Hong Kong, Malaysia, United Arab Emirates, Belgium, Japan, Korea, The Phillipines, Singapore, Taiwan, Thailand, Germany, and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GCJ and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.