MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ION; CATHETER

Model Number	490305-21
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
Additional Manufacturer Narrative
Intuitive surgical inc.(isi), has not received the da vinci product with an alleged issue to perform failure analysis.
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 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 the following additional information: nurse was only made aware of the small piece of metal in the tray once the operating lists was finished and sterile services received the tray for reprocessing.The instruments have been inspected, and it could not be seen any place the metal had come from.Nurse contacted the physician and she said that did not notice anything of concern and was not aware that a piece of metal had been found.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The full articulating catheter was analyzed and found with no external/physical damage.The catheters housing, tool channel, sensor connector, all input disk (no friction), shaft collar, and distal tip ring were all intact.No rattling noise was observed inside the catheter housing when manually shaken.No missing material or component was observed.The reported/mentioned small metal piece by the customer found in the tray was not returned with the catheter.The catheter passed all continuity test during in-house testing.Performed electrical continuity, full continuity leakage test, od leakage test and id continuity leakage test with no failures.The continuity full leak test was performed twice and passed on both attempts.The catheter passed air leak test twice in-house with no streaming bubbles observed.The fiber was inspected using the exfo scope, fibers appeared smooth, no signs of damage after second wet cleaning.The catheter was fully functional.No product issue was found.The complaint regarding a small metal piece was found in the bottom of the tray was not confirmed by failure analysis.

• Brand Name: ION
• Common Device Name: CATHETER
• 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: 24299549
• Report Number: 2955842-2026-03737
• Device Sequence Number: 10153995
• Product Code: EOQ
• UDI-Device Identifier: 00886874124796
• UDI-Public: (01)00886874124796(11)251009(10)M12251013
• 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): 03/12/2026

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: 490305-21
• Device Catalogue Number: 490305
• Device Lot Number: M12251013 0007
• 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: 02/09/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2025
• 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