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

Model Number	490206-02
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during central processing, the peripheral vision probe had leak distal tip.The customer reported event has no report of patient injury.
Additional Manufacturer Narrative
The peripheral vision probe has been returned and evaluated by the failure analysis (fa) team.The vision probe was found to have one of its fiber protruding.Visual inspection was performed on the vision probe distal tip and immediately noticed the protruding fiber.The protruding fiber likely caused the air leak test failure.Visual inspection found no damage on connector and pins.There was no fluid intrusion observed in the cable adapter during initial inspection.No fluid was obtained during the fluid extraction procedure.Additionally, the vision probe was found to have air leak test failure.The vision probe was placed on an in-house air leak tester resulting in a failure.During air leak test a steady stream of bubbles was observed coming from the vision probe tip, likely due to the protruding fiber.Additionally, the vision probe was found to have a distal tip discoloration.Visual inspection was performed and the vision probe distal tip observed yellow spot on the band.Discoloration at the tip is likely a result of material oxidation of stainless steel under the laminated jacket.The vision probe was found to have kinked shaft.Visual inspection was performed and found a minor kink on the shaft.The kinked shaft is located approximately 247mm from the distal tip.Additionally, the air leak test failed with steady stream of bubbles observed coming from the distal tip.Air leak test was performed per user manual and failed with a steady stream of bubbles observed coming from the distal tip.One of the two illumination fibers was observed to be protruding 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 protruding fiber is due to a failure of the adhesive bond that secures the fiber in the tip of the probe.The air leak test failure was observed at the location of the protruding illumination fiber and is due to an insufficient seal at the distal tip.There was 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.Additionally, discoloration was observed at the vision probe tip.A slight kink was observed approximately 247mm from the distal tip.

• 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: 24682770
• Report Number: 2955842-2026-17672
• Device Sequence Number: 15962999
• Product Code: EOQ
• UDI-Device Identifier: 00886874121184
• UDI-Public: (01)00886874121184(11)250807(10)M18250807
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 03/24/2026

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: M18250807 0015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2025
• 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