Recall Z-1431-2013 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
| Date | May 29, 2013 (initiated May 8, 2013) |
| Status | Terminated |
| Reason | Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments. |
| Root cause | Device Design |
| Action | Intuitive Surgical sent an "Urgent Medical Device Correction" letter dated May 8, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Customer Service at 800-876-1310 for questions regarding this notice. |
| Quantity | 697 units - all products |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of AL, CA, CO, FL, IL, KY, MI, MS, NJ, NY, PA, TX, UT, VA, WA, and WI, and the countries of Austria, Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Norway, Qatar, Romania, Spain, Sweden, Switzerla |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012833 | INTUITIVE SURGICAL BIPOLAR FORCEPS Intuitive Surgical, Inc., Nov 16, 2001 |