Recall Z-0841-2019 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
daVinci Harmonic ACE Curved Shears
| Date | Jan 16, 2019 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 43755 inserts |
| 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 |
| FDA record | Open on fda.gov |