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Recall Observatory FDA recall evidence

Device product

daVinci Harmonic ACE Curved Shears

Z-0841-2019

January 16, 2019

Class II

Product summary

Firm
Intuitive Surgical, Inc.
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

    reason.sterility_assurance · v1.0.0

    breach in sterility