MAUDE Adverse Event Report: AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. ARTISAN LINK PRO SPECIAL STAINS SYSTEM; AUTOMATED SLIDE STAINER

Model Number	AR310
Medical Device Problem Codes	Fire (1245); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d4: the additional unique device identifier (udi) number consists only of the gtin because a complete manufacture date could not be provided.
Event or Problem Description
A united kingdom customer reported that their artisan instrument was not adequately de-waxing slides.A field service engineer (fse) contacted the customer and provided guidance on checking the instrument's heaters.The customer elected to perform the heater checks individually and indicated they would follow up with the field service engineer (fse) upon completion.After completing the heater checks, the customer reported that during testing they heard a "pop," followed by smoke and visible flames originating from the instrument.A co2 fire extinguisher was used to extinguish the flames, and the fire brigade was contacted.The customer was advised to not power-on the instrument.The fse went to the customer's site to inspect the instrument and determined that upon inspection, evidence of a short circuit on the heater control board was identified, including visible scorch marks.Liquid residue was also observed on the heater boards and associated cabling.The fse removed the rear panel for further examination of the instrument and couldn't find anything out of place or on any of the panels.The instrument was taken out of service, and the artisan instrument was deemed non-repairable.While the issue had no safety impact since there was no direct, or indirect, user harm reported for this event; it is being reported due to the potential for harm.Therefore, this report is being filed as part of agilent's commitment to due diligence reporting.

• Brand Name: ARTISAN LINK PRO SPECIAL STAINS SYSTEM
• Common Device Name: AUTOMATED SLIDE STAINER
• Manufacturer (Section D): AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.; no.1 yishun avenue 7; singapore north east, sgp 76892 3; SN 768923
• Manufacturer Contact: chris stevenson ; 5301 stevens creek blvd; santa clara, CA 95051
• MDR Report Key: 25782466
• Report Number: 3003423869-2026-00002
• Device Sequence Number: 21218685
• Product Code: KPA
• UDI-Device Identifier: 05700571108451
• UDI-Public: 05700571108451
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2026

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: AR310
• Device Catalogue Number: AR31030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown