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

Model Number	AR310
Medical Device Problem Codes	Leak/Splash (1354); Device Remains Activated (1525); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported dirty inconsistent staining and that they have discontinued using positions 9-16 on the instrument as the heat required stains are not turning out well in those positions.On an unknown date, the bulk waste was not emptied which overflowed onto the clips and spill tray.The customer noticed that all the subsequent slides were coming out dirty or with weak staining.The customer also mentioned that positions 9 and 23 did not cool down after the run was completed.This was discovered when the customer was cleaning the pads with a wet gauze pad.An agilent field service engineer (fse) serviced the instrument and verified that due to the overflow in the instrument, the heater boards and heaters were no longer working.The fse replaced all required components.The instrument is fully operational and ready for use.Reagent or liquid spilling onto the heater control board has the potential to short circuit the heater control board and not provide accurate data flow and signal transmission to the respective heater plates causing them to remain on when unintended.While there was no direct or indirect user harm reported for this event; it is being reported due to the potential for harm if the event were to reoccur.Therefore, this report is being filed as part of agilent's commitment to due diligence reporting.
Additional Manufacturer Narrative
This supplemental was submitted to document the correction of codes in h6.The following fields were updated: b4, g6, h2, h6, h11.
Event or Problem Description
On 02-oct-2025, the customer reported dirty inconsistent staining and that they have discontinued using positions 9 through 16 on the artisan instrument as the heat required stains are not turning out well in those positions.The customer further reported that in relation to this event, on 01-oct-2025, they had forgotten to empty the bulk waste containers, resulting in waste overflow onto the clips and spill tray inside the instrument.Since the overflow, all subsequent slides were coming out dirty or with weak staining.Lastly, the customer mentioned that positions 9 and 23 did not cool down after the run was completed.This was discovered when the customer was cleaning the heaters with a wet gauze pad.An agilent field service engineer (fse) serviced the instrument and verified that due to the overflow in the instrument, the heater boards and heaters were no longer working.The fse replaced all required components.The instrument is fully operational and ready for use.Reagent or liquid spilling onto the heater control board has the potential to short circuit the heater control board and not provide accurate data flow and signal transmission to the respective heater plates causing them to remain on when unintended.There was no direct or indirect patient harm or user harm reported in relation to this event.
Additional Manufacturer Narrative
This supplemental was submitted to document the correction of the event date and verbiage in b5.The following fields were updated: b3, b4, b5, g6, h2, h11.

• Brand Name: ARTISAN LINK PRO SPECIAL STAINING 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; SG 768923
• Manufacturer Contact: benjamin gaither ; 1834 state highway 71 west; cedar creek, TX 78612
• MDR Report Key: 23435986
• Report Number: 3003423869-2025-00047
• Device Sequence Number: 15591507
• Product Code: KPA
• UDI-Device Identifier: 05700571108451
• UDI-Public: (01)05700571108451(11)220305
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2026

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: 10/02/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 03/06/2026; 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2022
• 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