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	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an ion-assisted lung biopsy procedure, the patient developed a pneumothorax requiring chest tube placement, and the procedure was subsequently aborted.The target nodule measured 1.6 cm and was located in the anterior right upper lobe, adjacent to or continuous with the pleural surface.The pneumothorax was detected via fluoroscopy.Positive end-expiratory pressure (peep) was lowered and a chest tube was placed to manage the event.The patient had been admitted to the hospital one week prior to the procedure and remained hospitalized for an additional week following the procedure due to a prolonged air leak, which required chemical pleurodesis.Regarding the procedural approach, tomosynthesis was utilized during the case as it was available on the institution's imaging equipment.When the target was updated using the tomosynthesis signal rather than maintaining the original mapping created in planpoint, the guidance and warning information regarding distance to the pleural surface was no longer available to the physician.The physician acknowledged that this loss of pleural proximity data may have been a contributing factor to the pneumothorax, and reflected that utilizing radial endobronchial ultrasound (ebus) may have been a more appropriate approach for this case.The physician noted, however, that given the nodule's proximity to the pleural surface, a pneumothorax would likely have occurred regardless of the modality used.No malfunction or device-related issues were identified with the ion system, instruments, or accessories.The physician did not attribute the event to a deficiency of the ion system, but noted that the transition from planpoint mapping to tomosynthesis-based targeting represented a workflow consideration that may have influenced the clinical outcome.
Additional Manufacturer Narrative
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.The system operated as expected.When the target is updated, the lesion-to-airway relationship does not persist from the ct scan or planpoint.To restore the guidance and warning information regarding distance to the pleural surface, the user may simply undo the target update.This is covered in the instruction for use.

• 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: 50771016
• Report Number: 2955842-2026-38924
• Device Sequence Number: 9488390
• Product Code: EOQ
• UDI-Device Identifier: 00886874116234
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/15/2026

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: 08/19/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Ion Endoluminal System.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 121 LB
• Patient Race: Black Or African American