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

Model Number	380748-65
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an ion lung biopsy procedure, and developed a pneumothorax which required hospitalization.The target nodule was located in the right upper lobe along the fissure.The physician believed the pneumothorax may have been caused by the biopsy brush, noting that the brush was inserted too far by the assisting nurse.The physician reported feeling significant resistance upon withdrawal of the brush, which was found to have blood on it upon removal.The pneumothorax was managed conservatively without the need for chest tube placement.The patient's condition improved by the following morning, and the patient was subsequently discharged.It is unknown when and how the pneumothorax was identified.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information; however, no further details have been received as of the date of this report.
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: 50871182
• Report Number: 2955842-2026-39660
• Device Sequence Number: 9314168
• 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): 09/23/2026

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: 380748
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2023
• 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
• Patient Sex: Unknown