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

Model Number	490206-02
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after an ion endobronchial lung biopsy procedure, the customer stated that a small metal piece was found in the bottom of a tray.The customer reported to be unsure if it had broken off the catheter or the peripheral vision probe.It was indicated that the procedure was completed with no reported patient harm, adverse outcome, injury or procedural delay.No fragment fell into the patient.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: it was stated that the physician did not notice anything of concern and was not aware that a piece of metal was found.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the ion for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive an ion product to perform failure analysis.The peripheral vision probe was analyzed, and the complaint was not confirmed by failure analysis.The vision probe was found with no external/physical damage.The instrument¿s housing connector plug, shaft (no kink) and illumination fibers were all intact.No rattling noise was observed inside the connector plug housing when manually shaken.No missing material or component was observed.There was no sign of fluid intrusion found in the cable adapter.Attempted to extract fluid from the vision probe but no fluid was acquired.Installed the vision probe on in-house system with no issue and no generated error message during testing.The led light was illuminated, and clear image was observed.The vision probe was tested multiple times with all initialization and orientation passing from in-house system.Passed lung mapping registration.The vision probe passed air leak test.The instrument was fully functional.No product issue was found.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 24253917
• Report Number: 2955842-2026-03106
• Device Sequence Number: 18634515
• Product Code: EOQ
• UDI-Device Identifier: 00886874121184
• UDI-Public: (01)00886874121184(11)251002(10)M10251003
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K212048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: M10251003 0065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2025
• 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