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U.S. Department of Health and Human Services

Class 2 Device Recall VirtoSaph Plus Endoscopic Vessel Harvesting System

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 Class 2 Recall
VirtoSaph Plus Endoscopic Vessel Harvesting System
see related information
Date Posted July 21, 2011
Recall Status1 Terminated on July 27, 2011
Recall Number Z-2854-2011
Recall Event ID 59189
Premarket Notification
510(K) Number
K092789 
Product Classification Laparoscope, General & Plastic Surgery - Product Code GCJ
Product VirtuoSaph Plus Endoscopic Vessel Harvesting System , REF VSP550, Sterile, Terumo Cardiovascular System Indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels and dissection of blood vessels of the extremities. Extremity procedures include tissue dissection and/or vessel harvesting along the saphenous vein for coronary artery bypass grafting and peripheral artery bypass grafting.
Code Information Catalog #: VSP550 Lots: 0XK, 0YK, 09K.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor, Michigan 48103-9586
Consumer Instructions No consumer action necessary
Manufacturer Reason
for Recall
Terumo Cardiovascular Systems received four (4) complaints from a single customer about tunnel breathing/inadequate insufflation with the VirtuoSaph Plus Endoscopic Vessel Harvesting System during cases in a limited production launch situation. Teumo's investigation identified issues with the devices's capability to maintain pressure within the tunnel.
FDA Determined
Cause 2
DESIGN: Device Design
Action Terumo Cardiovascular Systems contacted the one customer to this device on June 10, 2010 by telephone. There was one consignee. The firm contacted this one consignee by phone on 6/10/2010. There were 2 contacts at this one consignee. The recalling firm contacted both of the contacts on 6/10/2010. The consignee was asked to dispose of remaking inventory of devices. The consignee said had disposed of the product. For information on this recall call (734) 741-6173.
Quantity in Commerce 35 units
Distribution Nationwide (USA) Distribution including the state of New York.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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