Recall Z-1118-2015 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use with the da Vinci Surgical System - IS2000 and IS3000. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System
| Date | Feb 13, 2015 (initiated Jan 21, 2015) |
| Status | Terminated |
| Reason | Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips. |
| Root cause | Error in labeling |
| Action | A Field Safety Notice entitled, Urgent Medical Device Correction, and dated, January 21, 2015, were sent to customers. The letter identified the problem and the reason for the recall as well as the risk to health. Customers are asked to ensure that all affected personnel are informed of the notice. Additionally, customers are to discard their current Harmonic Ace IFUs. Customers are to refer to the specified manual, reference guide, and instruction card mentioned in the letter. A copy of the notice is to be retained with the da Vinci Standard, S or Si user manual. Intuitive Surgical will |
| Quantity | 12,467 - both sizes |
| Distribution | Worldwide Distribution -- US, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, India, Israel, Italy, Japan, Lebanon, Mexico, Monaco, Netherlands, Pakistan, Panama, Puerto Rico, Qatar, Romania, Russian |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093217 | 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM) Intuitive Surgical, Inc., Jan 21, 2010 |