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	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during endobronchial lung biopsy procedure, a customer called at start of case to report problems with system, it was stated that the catheter was pulling in one direction.Technical service engineer (tse) suggested double checking clinical setup for obstructions or pressure on system.Tse suggested replacing the catheter, this resolved the issue.The procedure was completing as planned with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the catheter assembly instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the catheter would not center and was pulling to the side.Intuitive surgical, inc.(isi) has received the catheter for evaluation.However, the failure analysis has not been completed yet.A follow-up mdr will be submitted if additional information is obtained.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the catheter associated with this complaint and completed investigations.The reported issue with the instrument could not be replicated nor confirmed.Visual inspection was performed, and no external physical damages were observed.No residue, debris or fluid were observed on the housing, green sensor connector, and tool channel.No noise or fluid were observed in the housing when the housing was shaken.The fiber was inspected using the exfo scope and the fiber appears to be smooth with no signs of damage.Some debris was found on the fiber but was able to be cleaned using the sensor connector cleaner and by performing the wet clean method.The air leak test was performed and passed twice using an in-house reprocessing cover.No steady stream of bubbles observed, and the leak tester was able to maintain 140-180mmhg air pressure.Electrical continuity was tested and passed using a multimeter.The full continuity leak test was performed and passed twice.The instrument was fully functional.No product issue was found.
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: 21955384
• Report Number: 2955842-2025-18295
• Device Sequence Number: 20649232
• Product Code: EOQ
• UDI-Device Identifier: 00886874124796
• UDI-Public: (01)00886874124796(10)K14241125
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2025

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: K14241125 0018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 05/06/2025; 06/04/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 05/28/2025; 06/27/2025
• 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: 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: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown