—#170510

Product

daVinci Harmonic ACE Curved Shears

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K093217, K112584
Affected lot / code info: All Lots

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Bldg 101, Sunnyvale, California 94086-5304

Distribution

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

Timeline

Recall initiated: 2019-01-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #170510. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.