Device 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
Z-1118-2015
Product summary
- Event
- Event 70275
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,467 - both sizes
- Official record key
device-enforcement:Z-1118-2015
Official wording
Reason: Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.
Code information: PN 400275, 420275, and 420272.
Distribution pattern: 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, Thailand, Turkey, and the United Kingdom.
Derived failure modes
-
Unknown
Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.