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

Model Number	490206-01
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive an ion product to perform failure analysis.The peripheral vision probe was placed on an in-house system and passed initialization on all 10 attempts with no error code observed.The instrument was docked successfully on an in-house catheter and tested with an in-house lung model, resulting in fully functional set up that successfully registered to an in-house patient plan.During testing, images from the vision probe were up to standard and the camera fibers were illuminated.No errors occurred during testing.Visual inspection found no damage on connector and pins.There was no physical damage observed on the camera.There was no fluid intrusion observed in the cable adapter.No fluid was obtained during the fluid extraction procedure.No kinks and puncture/tear were observed throughout the shaft.The vision probe was found to have a dislodged fiber.Visual inspection was performed and found one of the fibers completely black.A tweezer was used to check if the fiber was present, however it appears the fiber was dislodged.The vision probe was found to have air leak test failure.The vision probe was placed on an in-house air leak tester and failed immediately.A steady stream of bubbles and air was leaking from the distal tip, most likely from the dislodged fiber, which caused air leak test failure.Additional engineering review was performed.For clarification, the vision probe failed the air leak test, replicating the report of "problems with the vision probe during processing.Would not pass test." however, no functional issues were observed when the vision probe was installed on the in-house system.Air leak test failed with steady stream of bubbles observed coming from the distal tip.Upon visual inspection of the tip, one of the two illumination fibers was observed to be recessed.Probe was opened up to check backend components.No damage or fluid intrusion was observed.The recessed fiber was removed from the shaft to inspect the distal tip.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 during manufacturing.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.Note that no confirmed missing pieces were observed.Additionally, the wally camera paddle board (wcpb) was fully seated with the printed circuit assembly (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.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.Discoloration was observed at the vision probe tip.Discoloration at the tip is likely a result of material oxidation of the stainless steel under the laminated jacket.Corrosion was observed on the heatsink.The oxidized nickel plating is likely due to exposure to reprocessing chemicals, such as peracetic acid (paa).The probable root cause is attributed to a fiber installation failure during the manufacturing process.The fiber was found dislodged from its intended position causing the vision probe to fail during the leak test.
Event or Problem Description
During central processing, it was reported peripheral vision probe would not pass test and did not work when put on ion system.The customer reported event has no report of patient 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: 23724563
• Report Number: 2955842-2025-47562
• Device Sequence Number: 10691903
• Product Code: EOQ
• UDI-Device Identifier: 00886874121184
• UDI-Public: (01)00886874121184(10)M10250528
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/04/2025

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: 490206-01
• Device Catalogue Number: 490206
• Device Lot Number: M10250528 0011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2025
• 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