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

Model Number	490305-01
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/23/2025
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 the da vinci product with an alleged issue to perform failure analysis.Visual inspection was performed and the catheter was found to have a broken housing.The broken pieces were returned and no housing pieces appear to be missing.Due to the returned condition of the catheter, the air leak test was unable to be performed.Electrical continuity was tested and passed using a multimeter.The full continuity leak test was performed and passed twice.Broken housing is most likely caused by using compressed air at a high psi.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.Additional observations not reported by site: the catheter was found to have a broken chassis near the weld where the chassis meets the housing.The broken piece, measuring approximately 14.18mm x 3.56mm in size, was not returned with the catheter.The fiber was inspected using the exfo scope and the fiber appear to exhibit fluid intrusion.Dried fluid and debris were observed on the fiber's external ferrule, contact and core regions.The probable root cause of the failure analysis findings was attributed to misuse of the instrument.
Event or Problem Description
It was reported that during central processing when conducting the continuity test, the head broke into several pieces.According to the tech it burst open on the processor.There was no report of patient involvement.

• 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: 22504033
• Report Number: 2955842-2025-29769
• Device Sequence Number: 9303280
• Product Code: EOQ
• UDI-Device Identifier: 00886874124796
• UDI-Public: (01)00886874124796(10)K14250428
• 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
• Report Date (Section B): 06/23/2025

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: K14250428 0015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2025
• 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: 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: ION ENDOLUMINAL SYSTEM
• Patient Sex: Unknown