Device product

Ion Endoluminal System, REF: 380748-65

Z-2720-2024

July 12, 2024

Class II

Product summary

Firm: Intuitive Surgical, Inc.
Event: Event 95046
Status: Ongoing
Classification: Class II
Quantity: 3 units
Official record key: device-enforcement:Z-2720-2024

Official wording

Reason: There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways.

Code information: UDI: 00886874116234/ System Serial Number/System Cart Serial Number: EN1230/10591271; EN1241/10591273; EN1231/10583014

Distribution pattern: US Nationwide distribution in the states of AZ and CA.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways.