MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC Ion; System Cart

Model Number	380748-65
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	08/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an ion endobronchial lung biopsy procedure, the patient developed a pneumothorax in the left upper lobe (lul) requiring a chest tube and hospitalization.Per the physician, there were no issues with the ion system and the biopsy itself caused the pneumothorax.
Additional Manufacturer Narrative
There was no allegation that a malfunction of an ion system, instrument, or accessory occurred during the procedure.

• Brand Name: Ion
• Common Device Name: System Cart
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; +1(408)523-2100
• MDR Report Key: 50690757
• Report Number: 2955842-2026-38163
• Device Sequence Number: 5927286
• Product Code: EOQ
• UDI-Device Identifier: 00886874116234
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K182188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 380748-65
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Ion Endoluminal System.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male