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

Model Number	490206-02
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The peripheral vision probe instrument was analyzed and found to have initialization failures.The probe was tested ten times on an in-house catheter and system and failed to initialize during each attempt.The system logs recorded error codes 48215 (¿sensor start failure¿) and 28203 (¿connection error¿).Due to these initialization failures, no image was displayed, and the led light at the distal tip did not illuminate.A review of the system error logs found error confirming the event occurred in the field.Visual inspection found no external damage to the housing or fluid in the cable adapter.Additional observations not reported by the site included a kinked shaft approximately 146 mm from the distal tip, which appeared slightly pinched.Corrosion was observed on the connector magnet, characterized by a white, hazy residue.The illumination fibers at the distal tip appeared blacked out or hollow.The instrument was transferred to failure analysis engineering for further analysis.The investigation further confirmed the customer-reported complaint and replicated the issue during in-house testing.Review of workstation component communication log (wccl) trace logs for en1187 confirmed initialization failures associated with error 28203.The probe failed to initialize during ten attempts in primary failure analysis and during five additional attempts in advanced testing.Visual inspection reconfirmed the slightly kinked shaft located 146 mm from the distal tip.Both illumination fibers were found recessed from the distal tip, one fully and one partially, indicating a failure of the adhesive bond that secures the fibers.Fluid and corrosion were observed on the boards, suggesting fluid intrusion through the distal tip where fibers had recessed.Component swap tests indicated that the initialization failure was linked to both the connector plug and the camera subassembly.An additional observation unrelated to the reported complaint found that the traces were narrow, likely due to a supplier setup or templating error during manufacturing.However, since the traces were centered and made contact correctly, this condition was not considered contributory to the initialization failures.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.The probable root cause of the kinked shaft is attributed to damage during use or reprocessing.The vision probe can become damaged when improperly handled or applying excessive force while inserting it down and removing it from the catheter tool channel.
Event or Problem Description
It was reported that during an ion endobronchial lung biopsy procedure, the peripheral vision probe instrument kept failing and it was unable to use.The diagnostic procedure was aborted with no patient involvement.

• 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: 23361666
• Report Number: 2955842-2025-42498
• Device Sequence Number: 17252213
• Product Code: EOQ
• UDI-Device Identifier: 00886874121184
• UDI-Public: (01)00886874121184(11)241107(10)S12241107
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/22/2025

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: S12241107 0013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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