Recall Z-1811-2008 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODE; S Cardiac Probe Gasper Instrument, Model IS2000, Part Number 420215-02; Product is manufactured and distributed by Intuitive Surgical, Inc. Sunnyvale, CA . The IS2000 CPG is used during cardiac ablation procedures.
| Date | Sep 17, 2008 (initiated Apr 18, 2008) |
| Status | Terminated |
| Reason | The product has a software interface problem. When the product is connected to the da Vinci IS2000 System it will not allow the System to recognize the Instrument which makes the IS2000 CPG instrument nonfunctional at all sites. Risks associated are loss of operability of the instrument, delay in surgery, and loss of dexterity. |
| Root cause | Software design |
| Action | On April 18, 2008 an Urgent Device Recall letter was issued to customers. Consignees were notified via e-mail and were instructed to return the product. Customers were instructed to segregate the product in a secure area for Intuitive Surgical CSRs. If you have any questions contact Karen Uyesugi at (408) 523-2100. |
| Quantity | 11 |
| Distribution | Class II Recall - Nationwide Distribution --- including states of NC, OH, GA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070947 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPER Intuitive Surgical, Inc., Feb 14, 2008 |