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

Model Number	380748-63
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	08/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an ion transbronchial lung biopsy procedure, the patient developed a pneumothorax.The biopsied lesion measured 3.3 x 2.7 cm and located in the superior segment of the left lower lobe abutting the pleura and fissure.The procedure was completed without complication.However, the physician noted that the needle or forceps may have contacted the fissure or pleura.After the procedure, the patient developed sharp, pleuritic chest pain following a heavy coughing episode.The physician believed the coughing may have induced the pneumothorax.The ion system did not exhibit any issues that may have contributed and the pneumothorax could have occurred with another biopsy modality.A post-procedure chest x-ray identified the pneumothorax, and a subsequent computed tomography (ct) confirmed a moderate-sized pneumothorax.It did not increase in size.A 10 french chest tube was inserted, and the patient received pain control with acetaminophen, opioids, and a lidocaine patch, as well as supplemental oxygen.The patient was admitted for 4 days and 3 nights.The chest tube was removed on day 2, but the patient remained hospitalized longer due to frailty and was then discharged home.The biopsy revealed atypical cells but no definitive diagnosis.
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.

• 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: 50773193
• Report Number: 2955842-2026-38524
• Device Sequence Number: 9717620
• Product Code: EOQ
• UDI-Device Identifier: 00886874116234
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 380748-63
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2023
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 322 LB
• Patient Race: White