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

Model Number	380748-60
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after ion endobronchial lung biopsy procedures, an unspecified number of patients returned with infections.The customer reported that there was recent water intrusion in ion catheters, but it was unknown if these infections were related to ion catheters.An intuitive surgical, inc.(isi) field service engineer (fse) performed a field evaluation, catheter and flexible instrument manipulator (fim) inspections were performed, and water evidence was found to be present.
Additional Manufacturer Narrative
An isi ion endoluminal reprocessing trainer conducted on-site observations in active cases as well as reprocessing.Observations were completed across the procedural, transportation, reprocessing and storage workflows.The observational findings identified potential factors, process gaps, and opportunities for improvement.Next steps included: continue collaboration with infection prevention, sterile processing, endoscopy and vendor partners to further evaluate findings and implement corrective actions when and where appropriate.It was also suggested to review results of ongoing water quality assessments; monitor adherence to updated point of use (pou) and reprocessing workflows; and contact the appropriate personnel with any questions, concerns, or requests for additional training and support.

• 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: 50820467
• Report Number: 2955842-2026-39060
• Device Sequence Number: 18810774
• Product Code: EOQ
• UDI-Device Identifier: 00886874116234
• UDI-Public: (01)00886874116234
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: 380748-60
• 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: 08/21/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2022
• 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