daVinci Harmonic ACE Curved Shears
FDA Recall Z-0841-2019 · Posted None
Recalling FirmIntuitive Surgical, Inc.
Recall StatusOpen, Classified
Product CodeNAY
Date Initiated2019-01-16
Product Quantity43755 inserts
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.
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.
Root Cause
Under Investigation by firm
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.