—#209213

Product

Ion Endoluminal System, REF: 380748-65

FDA product code: EOQ — Bronchoscope (Flexible Or Rigid)
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K182188
Affected lot / code info: UDI: 00886874116234/ System Serial Number/System Cart Serial Number: EN1230/10591271; EN1241/10591273; EN1231/10583014

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On July 12, 2024, Intuitive issued a "Urgent Medical Device Correction" notification to affected consignees via E-Mail. 1. This notice needs to be passed on to all those who need to be aware within your organization or functions where the potentially affected devices have been transferred. 2. Please retain a copy of this letter, place a copy with your affected system, and keep the acknowledgement form for your files. 3. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 4. An Intuitive Representative will schedule a site visit to perform replacement of the affected FIM assembly. Once replaced by the Intuitive Representative the Ion System can be used as designed. 5. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, regular mail, or fax.

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Sunnyvale, California 94086-5304

Distribution

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

Timeline

Recall initiated: 2024-07-12
Posted by FDA: 2024-08-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209213. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.