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

Model Number	490305-01
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the catheter associated with this complaint and completed investigations.The catheter was found to have a startup failure.The catheter was seated on an in-house system where it passed initialization on 4 out of 5 installs, however it failed with 28009 (fiber) on 1 out of 5 installs.When successfully initialized, the unit was capable of being driven through the in-house lung map and passed registration.In logs indicated the 28009-error code had a failure mode.The field logs for system en0775 indicate that the catheter had no error codes and was returned with 0 remaining lives.During external physical and visual inspections, the catheter showed signs of input disk friction when manipulated.The fiber was inspected using the scope.The fibers appeared to be clean and smooth with signs of fluid intrusion.
Event or Problem Description
It was reported that during an ion endobronchial lung biopsy procedure, the customer stated that the surgeon experienced a significant amount of catheter drift.It was stated that during the breath hold the catheter would drift inferiorly.The reported issue was resolved by replacing the catheter.The diagnostic procedure was completed with no reported injury.
Additional Manufacturer Narrative
The instrument has been evaluated by an intuitive surgical, inc.(isi) failure analysis engineer (fae).Customer log review showed the catheter was last installed on 09/24/2025 and was successfully initialized before the procedure, with no errors recorded.Logs confirmed that capacitive touch sensing and master control console scroll wheel motion correctly commanded catheter insertion, and trackball motion commanded articulation.The actual insertion and articulation positions followed the commanded movements as expected.Primary failure analysis showed the catheter passed startup testing 4 out of 5 installations on an in-house system and failed once with error code 28009.Analysis indicated the error was likely caused by a dirty fiber due to insufficient cleaning during the test setup rather than a device failure.Since logs showed normal catheter articulation and positioning and no issues were reproduced during testing, the customer complaint could not be confirmed or replicated.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 23340751
• Report Number: 2955842-2025-41807
• Device Sequence Number: 9470641
• Product Code: EOQ
• UDI-Device Identifier: 00886874124796
• UDI-Public: (01)00886874124796(10)K13241125
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 490305-01
• Device Catalogue Number: 490305
• Device Lot Number: K13241125 0019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2024
• 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