MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC Ion; Catheter

Model Number	490305-21
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ion endoluminal lung biopsy, the fully articulating catheter reportedly exploded in the nursing assistant's hands during the pre-disinfection step.No patient involvement.Intuitive surgical (is) obtained the following additional information regarding this event: it was confirmed that the nurse did not suffer any injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the catheter for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.

• 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 ; +1(408)523-2100
• MDR Report Key: 50851999
• Report Number: 2955842-2026-39585
• Device Sequence Number: 9936459
• Product Code: EOQ
• UDI-Device Identifier: 00886874124796
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K212048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: M17260129 0010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2026
• 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