Recall Z-2854-2011 ยท GCJ Laparoscope, General & Plastic Surgery
Terumo Cardiovascular Systems Corporation
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 d
| Date | Jul 21, 2011 (initiated Jun 10, 2011) |
| Status | Terminated |
| Reason | 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 | 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 | 35 units |
| Distribution | Nationwide (USA) Distribution including the state of New York. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092789 | VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM Terumo Cardiovascular Systems Corp., May 12, 2010 |