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Recall Observatory FDA recall evidence

Device product

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

Z-1464-2013

May 06, 2013

Class II

Product summary

Firm
Intuitive Surgical, Inc.
Event
Event 65168
Status
Terminated
Classification
Class II
Quantity
2101 consignees
Official record key
device-enforcement:Z-1464-2013

Official wording

Reason: 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).

Code information: Model number 420262

Distribution pattern: Worldwide distribution: US (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).