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	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an ion transbronchial lung biopsy procedure, the patient had developed a pneumothorax that required a chest tube.Two nodules were being biopsied and the lesions were 1.7cm located in the right middle lobe (attached to the pleura) and 1.1cm located in the right lower lobe.After biopsying the first nodule, an intraoperative ct scan identified a large pneumothorax, and a 14 gauge chest tube was inserted.The procedure was completed as planned.The physician believed the pneumothorax was caused by a spatial orientation issue and that it could have occurred with another biopsy modality.There were no issues with the ion system.After the procedure, the patient was hospitalized for 2 days then discharged home.The final diagnosis was non-small cell lung cancer.
Additional Manufacturer Narrative
There is no report that a malfunction of an ion system, instrument, or accessory occurred.Therefore, no products are expected for return for failure analysis evaluation.

• 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: 50789744
• Report Number: 2955842-2026-37991
• Device Sequence Number: 18534394
• Product Code: EOQ
• UDI-Device Identifier: 00886874116234
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/16/2026

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: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2025
• 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: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 94 LB