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	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the da vinci product with an alleged issue to perform failure analysis.Failure analysis found the primary failure of vision probe ¿ other to be related to the customer reported complaint.The vision probe was found to have two illumination fiber sticking out distally.Upon visual inspection, both illumination fiber was protruding approximately 4.12mm from the distal tip.The distal shaft did not appear to have any punctures or kinks.The illumination fiber seems detached from being glued from its location.There was no missing material observed.The root cause is not established.The vision probe will be transferred to engineering on the root cause of the protruding illumination fiber.During initial visual inspection, there were two protruding fibers observed, after air leak test, the other fiber seemed to go back inside the shaft/tip.The vision probe was found to have an air leak test failure.The vision probe had streaming bubbles during air leak testing; the streaming bubbles were located at the distal tip of the vision probe shaft most likely due to the dislodged/protruding illumination fiber.No fluid intrusion found in the cable adapter, no issue on the connector plug magnet and no bent connector pin/s was observed.The root cause is attributed to the dislodged illumination fiber.
Event or Problem Description
It was reported that during an ion endobronchial lung biopsy procedure, the customer stated that two light fibers were observed protruding from the distal end of a vision probe after it was reinserted following a biopsy.After the procedure, the vision probe was removed and reprocessed, during which it failed a leak test.The failure of the leak test, along with the protruding fibers, indicated potential damage to the probe.The probable root cause of the failure was attributed to component susceptibility to damage through external collisions, during use, or during reprocessing.The issue was resolved by using an alternate vision probe.The diagnostic procedure was completed with no reported injury.

• 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: 24646681
• Report Number: 2955842-2026-16900
• Device Sequence Number: 16004371
• Product Code: EOQ
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 09/21/2026

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: M10250919 0057
• Date Returned to Manufacturer: 03/11/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2025
• 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