Recall Z-1230-2011 ยท GCJ Laparoscope, General & Plastic Surgery
Terumo Cardiovascular Systems Corporation
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.
| Date | Feb 14, 2011 (initiated Jan 10, 2011) |
| Status | Terminated |
| Reason | 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 |
| Root 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 |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083194 | VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550 Terumo Cardiovascular Systems Corp., Jan 16, 2009 |