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

Model Number	490305-01
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive an ion product to perform failure analysis.The catheter was analyzed and failure analysis investigations confirmed the customer reported complaint of a bent catheter tip.The catheter was found to have a kink at the distal tip of the shaft.The catheter distal tip showed a kinked/smashed at 2.4mm from the distal tip of the shaft.Additionally, the air leak test was performed and failed.Bubbles were observed surfacing slowly from the distal tip of the shaft.Electrical continuity test was tested and passed using a multimeter.The catheter was transferred to engineering for further investigation on 6/20/2025.Upon visual inspection, catheter tip ring was observed to be missing.The catheter showed deformation of the tip and visible cracks on the solder.Cracked solder is most likely due to the damaged tip.The leak test failure observed during primary failure analysis is due the damaged tip.Review of vision probe feed for en0891 from 03/20/2025, the date the catheter was last used for a procedure, showed that the tip ring was present at the distal tip and that the catheter tip was undamaged.The catheter was subsequently installed, but not used for a procedure on 03/26/2025.Review of the vision probe feed from when the vision probe was attempted to be inserted down the catheter shaft showed that the tip was flattened and that the compressed tip ring was visible in the image.The catheter was reinstalled later on 03/26/2025 with the tip unflattened though still visibly deformed in the vision probe feed.The tip ring was not observed to be present on the final install.Therefore, it can be concluded that the tip damage occurred outside of the procedure and after the last use of the catheter during a procedure.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.The probable root cause of damaged tip and missing catheter ring tip is attributed to damage during use or reprocessing.Improper handling, such as excessive external load applied at tip, can result in damage.This issue can be resolved by using an alternate catheter to complete the procedure.The probable root cause of the failed leak test is attributed to a damaged catheter.A leak can occur between the housing and chassis or due to insulation damage along the shaft.This issue can be resolved by using an alternate catheter to complete the procedure.
Event or Problem Description
It was reported that prior to the start of an ion endobronchial lung biopsy procedure, the tip of the catheter is bent.There was 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: 22488104
• Report Number: 2955842-2025-29526
• Device Sequence Number: 8544330
• Product Code: EOQ
• UDI-Device Identifier: 00886874124796
• UDI-Public: (01)00886874124796(10)S10240926
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 06/20/2025

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: S10240926 0028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 07/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2024
• 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