MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ION; CONTROLLER

Model Number	380707-55
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	01/22/2026
Type of Reportable Event	Serious Injury
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.An ion product was not returned to intuitive surgical, inc.(isi) for evaluation.A system log review was not performed, as the reported complaint is not associated with any system errors or logged system events.Pneumothorax is a common complication for lung biopsies.It usually requires an integrity breach of the outer lining of the lung (e.G., needle puncture), which allows air to enter the pleural space, which may lead to a lung collapse.The probability and risk for pleural puncture through the endoluminal route increases with the lesion¿s proximity to the pleura.Risk of pneumothorax is included within the risk management report for the ion system.Based on the information, the reported event is related to a known inherent risk as documented in the labeling.
Event or Problem Description
It was reported that the patient experienced a pneumothorax after an ion biopsy procedure.The patient required chest tube placement.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the ion system did not exhibit any issues or unexpected behaviors that may have contributed to the pneumothorax.The lesion biopsied was 7mm from the pleura, and measured 9mm.It was located in the right lower lobe.No diagnosis has been determined.The patient experienced shortness of breath and chest pain, and an 8fr pigtail chest tube was placed.The patient was also placed on oxygen.The physician states it is unknown what caused the pneumothorax, which was moderate in size, and increased over time.In addition to medical treatment, the patient was admitted to the hospital.The patient has a history of chronic obstructive pulmonary disease and history of tobacco use.The patient remains hospitalized, pending discharge.

• Brand Name: ION
• Common Device Name: CONTROLLER
• 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 ; 4085232100
• MDR Report Key: 24364704
• Report Number: 2955842-2026-04119
• Device Sequence Number: 20119395
• Product Code: EOQ
• UDI-Device Identifier: 00886874116241
• UDI-Public: (01)00886874116241
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 02/17/2026

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: 380707-55
• Device Catalogue Number: 380707
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White