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 Codes	Chest Pain (1776); Dyspnea (1816); Pleural Effusion (2010)
Date of Event	07/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an ion microwave ablation procedure, the patient experienced post-ablation syndrome (inflammatory response) that required hospitalization.The post-ablation syndrome was noted to be a possible expected adverse event to the procedure, typically occurring a few days post treatment as the treated necrotic tissue is absorbed and the patients typically present with flu-like symptoms.After the standard one-night stay in the hospital, the medical team decided to keep the patient hospitalized because the patient experienced pain, shortness of breath, and pleural effusion.The patient was treated with unspecified intravenous antibiotic therapy and was hospitalized for 1 week and then discharged in stable condition.It was believed the complication could have possibly occurred via another modality and the adverse event was not deemed to be ion related and there were no issues with the ion system.
Additional Manufacturer Narrative
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: 50804501
• Report Number: 2955842-2026-38552
• Device Sequence Number: 8643771
• Product Code: EOQ
• UDI-Device Identifier: 00886874116234
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K182188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 380748-65
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/17/2026
• 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 Sex: Unknown