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

Model Number	490206-01
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The peripheral vision probe was analyzed and found to have one of the two illumination fibers was observed to be recessed.No obvious damage or kinks were observed on the shaft.Air leak test failed with steady stream of bubbles observed coming from the distal tip.Probe was opened up to check backend components.No damage or fluid intrusion was observed.Fiber service loops were observed in the backend.The fiber service loop in the backend allows for pistoning of the fibers within the vision probe shaft to accommodate changes in illumination fiber tension during catheter articulation and therefore vision probe shaft manipulation.Upon manual manipulation of the fibers, both fibers felt tight indicating that fiber movement might be slightly restricted.However, fiber service loops were present and no obstructions within the shaft id were observed, indicating that the fiber was likely sufficiently free to piston when the backend was closed.The recessed fiber was removed from the shaft to inspect the distal tip.Note that upon disassembly, the other fiber became recessed when fibers were pulled proximally in an attempt to remove the recessed fiber from the shaft.Adhesive was observed to be present on the distal tip of the fiber.The fiber appeared intact with no missing pieces.Minimal loctite was observed on the vision probe tip.The recessed fiber appears to be due to a failure of the adhesive bond between the vision probe tip and the adhesive that secures the fiber in the tip of the probe, which suggests that the loctite did not sufficiently bond to the vision probe tip.Air leak test failure was observed at the location of the recessed illumination fiber and is due to an insufficient seal at the distal tip.There is a potential for fragments of adhesive due to this failure mode as the adhesive bond failed at the distal tip which enters the patient.No confirmed missing pieces were observed.The wcpb was fully seated with the pca 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 wled.However, the traces appeared to be centered with the contact points and the probe initialized successfully during failure analysis in-house, so it does not appear likely that the narrowed traces led to any functional impact.Corrosion was observed on the heatsink.The complaint regarding malfunctioned prior to starting was confirmed by failure analysis.
Event or Problem Description
It was reported that prior to the start of an ion endobronchial lung biopsy procedure, the peripheral vision probe malfunctioned.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: 24284450
• Report Number: 2955842-2026-03654
• Device Sequence Number: 18287621
• Product Code: EOQ
• UDI-Device Identifier: 00886874121184
• UDI-Public: (01)00886874121184(10)M10250625
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/06/2026

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: 490206-01
• Device Catalogue Number: 490206
• Device Lot Number: M10250625 0049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• 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