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

Model Number	490305-10
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during central processing, the fully articulating catheter was not functioning.There was no report of patient involvement or patient injury.
Additional Manufacturer Narrative
The fully articulating catheter has been returned and evaluated by the failure analysis (fa) team.The catheter was tested for continuity and air leak and passed.Visual inspection was performed and found no damage to the catheter insulation.The vision probe was used to inspect the inside of the catheter shaft, and no liner damage was found.The catheter was found to have dirty fibers on the sensor connector.Upon inspection, a heat stake anomaly was identified on all five of the welded pegs that hold the board in place.It appears that these pegs were not fully compressed during heat staking.During primary failure analysis, it was observed that the material edges were peeling.Given that the adhesive edges were peeling due to the excess adhesive failure mode, there was a potential for fragments to fall into the patient if this failure mode were to recur.Further, inspection during primary failure analysis identified peeled excess loctite that was no longer observed during advanced failure analysis, indicating it had become detached.

• 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: 24990327
• Report Number: 2955842-2026-22921
• Device Sequence Number: 13287093
• Product Code: EOQ
• UDI-Device Identifier: 00886874124796
• UDI-Public: (01)00886874124796(10)K13250324
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/24/2026

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: K13250324 0004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• 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: 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