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

Model Number	380748-76
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an ion procedure, followed by bronchoalveolar lavage (bal) activities, a bal sample was found to be contaminated with the mycobacteroides chelonae (ntm) organism.The patient was asymptomatic and no infection was identified; therefore, antibiotics were not administered.There was no delay in the diagnosis related to the nodule biopsy.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) conducted an on site case observation and reprocessing room observations.Three areas for improvement were identified from these observations: use sterile water (cooled) when flushing through the tool channel and or bronchoscopes; refresher for point of use; and create a dedicated team for ion procedures.Concerning the reprocessing rooms, recommendations included: ensure all steps per ifu are being adhered to; ensure next step in reprocessing is being followed as quickly as possible, follow existing hour window like other scopes; have a dedicated team for ion reprocessing; refresher training for reprocessing teams; and ensure teams utilize intuitive learning for future competencies and training.Next steps from the genesis endoluminal reprocessing trainer includes refresher training for or and spd teams.Per the site's infection prevention program director, the infections were possibly attributed to, "potential ice used to cool saline for bronchoalveolar lavage," and corrective measures implemented at the facility included reeducation of reprocessing staff and using a sterile barrier over ice for cooling saline.Ice/water testing was in progress.There was no report of a malfunction of an ion system, instrument, or accessory occurred.Therefore, no product is expected for return to isi for failure analysis evaluation.

• 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: 50949024
• Report Number: 2955842-2026-40166
• Device Sequence Number: 15859171
• Product Code: EOQ
• UDI-Device Identifier: 00886874116234
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse Practitioner
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 380748-76
• Device Catalogue Number: N/A
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2025
• 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
• 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: Other
• Patient Sex: Unknown