PlainRecalls
FDA Devices Moderate Class II Terminated

da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments

Reported: June 12, 2013 Initiated: May 6, 2013 #Z-1464-2013

Product Description

da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments

Reason for Recall

Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262).

Details

Recalling Firm
Intuitive Surgical, Inc.
Units Affected
2101 consignees
Distribution
Worldwide distribution: US (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.
Location
Sunnyvale, CA

Frequently Asked Questions

What product was recalled?
da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments. Recalled by Intuitive Surgical, Inc.. Units affected: 2101 consignees.
Why was this product recalled?
Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262).
Which agency issued this recall?
This recall was issued by the FDA Devices on June 12, 2013. Severity: Moderate. Recall number: Z-1464-2013.