Recall Z-1118-2015
Intuitive Surgical, Inc. · initiated January 21, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: PN 400275, 420275, and 420272.
Reason for recall
Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.
FDA-determined cause: Error in labeling
Action taken
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 remove the Harmonic ACE IFU from all future shipments of the product. Representatives will be available by phone to answer questions related to the Correction.
Details
- Recall number
- Z-1118-2015
- Initiated
- January 21, 2015
- Posted by FDA
- February 13, 2015
- Terminated
- June 1, 2015
- Product code
- NAY – System, Surgical, Computer Controlled Instrument
- 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 Federation, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan…
- Recalling firm
- Intuitive Surgical, Inc., Sunnyvale, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1117-2015 Class II | HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci…Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to… | 01/21/2015Terminated |