daVinci Harmonic ACE Curved Shears
This recall is currently active, issued January 16, 2019. It was issued by Intuitive Surgical, Inc..
- Company
- Intuitive Surgical, Inc.
- Recall Initiated
- January 16, 2019
- Recall Number
- Z-0841-2019
- Quantity
- 43755 inserts
- Firm Location
- Sunnyvale, CA
- Official Source
- View on FDA website ↗
Reason for Recall
During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE Inserts may become damaged during transit. The potential damage includes pinholes and /or small openings (less than a few millimeters) on the pouch leading to a potential breach in sterility.
Distribution
US and Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, Kuwait, Lebanon, Mexico, Monaco, Netherlands, Pakistan, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Korea, Spain, Taiwan, Turkey, United Kingdom
Lot / Code Info
All Lots
Root Cause
Under Investigation by firm
Action Taken
A Stop Use Notification was sent to affected customers on December 19, 2018. This notification requested customers to return the device. The formal customer recall letter was sent on January 16, 2019.