Device product

IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Intuitive Surgical Inc.

Z-1870-2014

June 11, 2014

Class II

Product summary

Firm: Intuitive Surgical, Inc.
Event: Event 68531
Status: Terminated
Classification: Class II
Quantity: 20 units
Official record key: device-enforcement:Z-1870-2014

Official wording

Reason: In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which can make it hard to differentiate between tissue

Code information: 470027-20

Distribution pattern: Distributed in the states of FL, TX, and NY.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which can make it hard to differentiate between tissue