Recall Z-0110-2014 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, elec
| Date | Oct 30, 2013 (initiated Oct 2, 2013) |
| Status | Terminated |
| Reason | A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added instruction for use of these additional Single Site instruments including indication, warnings and precautions. |
| Root cause | Labeling Change Control |
| Action | The firm, Intuitive Surgical, sent an " Urgent Medical Device Correction" letter dated October 2, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure all affected personnel are fully informed of this notice; after receiving the updated manual, locate and discard all previous versions of the Single Site Instruments manual and replace with the new manual; complete and return the attached Acknowledgement Form via FAX to Intuitive Surgical, Inc., ATTN: REGULATORY COMPLIANCE, U.S. (408) 716-3040, or Scan and Email to: isi |
| Quantity | 286 boxes ( 6 instruments per box) for a total of 2,220 affected clinical product |
| Distribution | Worldwide distribution: US (nationwide) and countries of:Australia, Belgium, France, Italy and United Kingdom. . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112208 | INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES Intuitive Surgical, Inc., Dec 8, 2011 |