Device product
daVinci Harmonic ACE Curved Shears
Z-0841-2019
Product summary
- Event
- Event 81972
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 43755 inserts
- Official record key
device-enforcement:Z-0841-2019
Official wording
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.
Code information: All Lots
Distribution pattern: 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
Derived failure modes
-
Sterility assurance
breach in sterility