MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ION; VISION PROBE

Model Number	490206-02
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ion endobronchial lung biopsy procedure, the customer stated that the physician placed the vision probe into the catheter, and upon reaching the end, both the physician and staff observed a fiber visible in the view.The vision probe was then withdrawn, and a fiber was noted protruding from the tip of the probe.The diagnostic procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive an ion product to perform failure analysis.The ion vision probe was analyzed, and the light fiber was observed to be protruded distally from the tip with length of approximately 19.97mm.The vision probe was transferred to engineering for further investigation, to determine the root cause of the light fiber issue.Additional findings not reported by site: the vision probe was found to have leak test failure during in-house testing.A constant stream of bubbles was observed coming from the distal tip.The vision probe was found to have corroded/oxidized magnet.The magnet on the connector plug showed discoloration on its surface which indicates corrosion.Performed visual inspection and found no fluid intrusion inside the cable adapter.No damage on connector plug, connector pins and vision probe key.No kinked shaft was observed.On 18-feb-2026, the customer reported complaint was confirmed and replicated during engineering evaluation.One of the two illumination fibers was observed to be protruding approximately 20mm from the distal tip.Minimal adhesive was observed to be present on the distal tip of the protruding fiber.The protruding fiber appeared intact with no missing pieces.No damage or kinks were observed on the shaft.The vision probe was installed on an in-house system and successfully initialized with no errors observed.The vision probe was opened up to check backend components.No damage or fluid intrusion was observed.The air leak test failure observed at the location of the protruding illumination fiber identified during primary failure analysis and is due to an insufficient seal at the distal tip.Therefore, the air leak test failure is related to the customer complaint.There is a potential for fragments of adhesive or fiber due to this failure mode as the adhesive bond failed at the distal tip which enters the patient.Additional finding that is unrelated to the reported complaint: corrosion was observed on the heatsink.The oxidized nickel plating is likely due to exposure to reprocessing chemicals, such as peracetic acid (paa).The wally camera paddle board (wcpb) was fully seated with the board lock engaged.Wcpb traces were observed to be centered on the board but were observed to be narrow.It is likely that there was supplier setup/templating error during supplier manufacturing leading to the traces being too narrow.Narrow traces can lead to poor connection between the wcpb and the mating connector on the led.However, the traces appeared to be centered with the contact points and the vision probe initialized successfully during failure analysis in-house, so it does not appear likely that the narrowed traces led to any functional impact.The complaint was confirmed by failure analysis.The root cause is attributed to a failure in the manufacturing process.The protruding fiber is due to a failure of the adhesive bond that secures the fiber in the tip of the probe.

• Brand Name: ION
• Common Device Name: VISION PROBE
• 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: 24571913
• Report Number: 2955842-2026-15777
• Device Sequence Number: 8365856
• Product Code: EOQ
• UDI-Device Identifier: 00886874121184
• UDI-Public: (01)00886874121184(11)250717(10)M19250717
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 03/11/2026

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: 490206-02
• Device Catalogue Number: 490206
• Device Lot Number: M19250717 0042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2025
• 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