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	08/25/2026
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 chest tube placement and hospitalization.The target nodule measured 12 mm and was located in the right upper lobe, 3 mm from the pleural surface.The initial pneumothorax was not considered severe, and the physician elected to continue the procedure.However, a follow-up chest x-ray demonstrated an increase in pneumothorax size, necessitating chest tube placement for resolution.The physician did not attribute the pneumothorax to the ion system, noting it likely would have occurred via an alternative modality.The procedure had been classified as high risk preoperatively, and the pneumothorax was attributed to the patient's advanced age and significant fibrotic lung disease.No malfunction or device-related issues were identified with the ion system, instruments, or accessories.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this adverse event.There is no indication that the customer reported complication of pneumothorax was related to a product issue.There was no allegation that a malfunction of an ion system, instrument, or accessory occurred during the procedure.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.Field h10 is blank as there are no related report numbers.

• 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: 50840164
• Report Number: 2955842-2026-39459
• Device Sequence Number: 10301948
• Product Code: EOQ
• UDI-Device Identifier: 00886874116234
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/21/2026

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: 08/25/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2023
• 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: Required Intervention; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 149 LB
• Patient Race: White