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

Model Number	380748-44
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 transbronchial lung biopsy procedure, the patient experienced a tension pneumothorax.A prior lung resection for lung cancer significantly altered the patient's anatomy, shifting it up and causing the case to be technically more difficult.The physician biopsied a nodule located directly anterior to the heart within a very small remaining portion of lung tissue.The physician only used cryoprobe during the procedure and was reported to have been very careful in confirming positioning throughout.The patient was expected to be hospitalized overnight.Additional information was not provided.Intuitive surgical inc.(isi) has made multiple attempts to obtain additional information; however, as of the date of this report, no new information has been obtained.
Additional Manufacturer Narrative
A review of the event was conducted by an isi medical officer and the following additional information was provided: "a patient with prior lung resection surgery for lung cancer underwent an ion biopsy of nodule to evaluate for cancer recurrence.Per reports, patient developed a tension pneumothorax.No further information is available regarding the subsequent management or outcome of this complication.Bronchoscopy and biopsy is a minimally invasive procedure with a low overall complication rate.One prospective multicenter registry study of bronchoscopic biopsies of peripheral lung lesions reported 10 pneumothoraces in 581cases reflecting a rate of 1.7%.Another prospective multicenter international study of navigational bronchoscopy in 1,215 subjects reported a total pneumothorax rate of 4.3% and a rate of 2.9% requiring hospitalization or intervention.A recent meta-analysis of navigational bronchoscopy in 10,381 patients reported a pneumothorax rate of 2.5%.A subsequent case series of ion robotic assisted bronchoscopies including 415 cases reported a pneumothorax rate of 3.1% with a total of 7 (1.7%) patients requiring a chest tube.There was no allegation of a malfunction of the ion system, instrument or accessories associated with the reported complication.Based on the available data the reported pneumothorax is a known and expected complication of the procedure.Ost de, ernst a, lei x, et al.Diagnostic yield and complications of bronchoscopy for peripheral lung lesions.Results of the aquire registry.Am j respir crit care med.2016;193(1):68-77.Folch ee, pritchett ma, nead ma, et al.Electromagnetic navigation bronchoscopy for peripheral pulmonary lesions: one-year results of the prospective, multicenter navigate study.Journal of thoracic oncology.2019.Kops sep, heus p, korevaar da, et al.Diagnostic yield and safety of navigation bronchoscopy: a systematic review and meta-analysis.Lung cancer.2023.Brownlee ar, watson jjj, akhmerov a, et al.Robotic navigational bronchoscopy in a thoracic surgical practice: leveraging technology in the management of pulmonary nodules.Jtcvs.2023.".

• 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: 50820030
• Report Number: 2955842-2026-39136
• Device Sequence Number: 13299921
• Product Code: EOQ
• UDI-Device Identifier: 00886874116234
• UDI-Public: (01)00886874116234
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 380748-44
• Device Catalogue Number: N/A
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2021
• 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: Life Threatening
• Patient Sex: Female