MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ION; CATHETER

Model Number	490305-10
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive an ion product to perform failure analysis.The catheter was analyzed and found to have a sensor connector issue.Catheter was observed to have failed the startup test with 2 instances of error 28009 observed in the error logs.During primary failure analysis, the catheter was installed on an in-house system 5x and passed the startup test for each install.28009 errors are indicative of a fiber connection related failure.Flat (field logs analysis tool) was used to analyze the likely cause of the field 28009 errors and pointed to termrl, or termination reflection, as the likely failure mode.The return product was reviewed with an ion data engineer.Analysis of the log files showed that the grating amplitude for multiple cores dips near the termination, leading to the bend difference being highest at the termination.This bend difference due to a drop in the gratings at the termination is due to poor laser coherence when the gratings were written during manufacturing.The catheter sensor was also found to have low power.A low power sensor is more likely to fail for low power even on normal power system when compared with a catheter sensor with normal power.Given that higher power systems can overcome low gain and low signal amplitude and allow the catheter to pass startup tests, it is likely that the field system the catheter was installed on during the device install supplied lower power than the power supplied by the system used during manufacturing, contributing to startup test failures when the borderline low power unit was installed.As a result, the low power may have also contributed to the 28009 errors.Additional information provided by advance failure analysis: the catheter was found to have dirty fibers on the sensor connector.During visual inspection, excess material was found on top of the fiber termination at the catheter tip.During primary failure analysis, it was observed that the material edges were peeling.This peeling was also observed during advanced failure analysis, but a section of the peeling material identified during primary failure analysis was no longer apparent and had likely become detached.The material at the tip was found to be the adhesive used to pot the fiber during the fiber integration station in manufacturing.The catheter was returned with all lives remaining, indicating that manufacturing contributed to the failure mode.From review with a manufacturing engineer, it is likely that excess loctite adhesive was dispensed during assembly and the subsequent inspection for excess loctite was missed.Subsequently, it is likely that handling of the catheter after packaging and reprocessing and prior to a procedure caused the edges of the excess adhesive to peel.The probable root cause is attributed to dirty or damaged fibers.
Event or Problem Description
It was reported that prior to the start of an ion endobronchial lung biopsy procedure, the fully articulating catheter was unable to connect, had an error code.The diagnostic procedure was completed with no reported injury.

• Brand Name: ION
• Common Device Name: CATHETER
• 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 ; 4085232100
• MDR Report Key: 25074254
• Report Number: 2955842-2026-23716
• Device Sequence Number: 18748371
• Product Code: EOQ
• UDI-Device Identifier: 00886874124796
• UDI-Public: (01)00886874124796(10)K14240909
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K212048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 490305-10
• Device Catalogue Number: 490305
• Device Lot Number: K14240909 0026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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: Initial
• 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
• Patient Sex: Unknown