—#101568

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.

FDA product code: GCJ — Laparoscope, General & Plastic Surgery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K092789
Affected lot / code info: Catalog #: VSP550 Lots: 0XK, 0YK, 09K.

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Road, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: Nationwide (USA) Distribution including the state of New York.

Timeline

Recall initiated: 2011-06-10
Posted by FDA: 2011-07-21
Terminated: 2011-07-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #101568. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.