MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC. BENCHMARK ULTRA SYSTEM; SLIDE STAINER, AUTOMATED

Catalog Number	05342716001
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A leak was found coming from the reaction buffer block of the nozzle plate; one fitting was broken, and stains left by the reagent were observed along the fall path.The traces of liquid on the nozzle plate, base plate, and base frame show that the leak came from the fitting of the reaction buffer solenoid valve group placed on the nozzle plate.The liquid then continued its path along the cables to the power supply.The investigation is ongoing.
Event or Problem Description
We received an allegation of an issue with a benchmark ultra system.The customer allegedly heard a noise sounding like a short circuit associated with the sudden shutdown of the instrument.The customer reportedly smelled a strong burning odor, and smoke was coming from the instrument.The laboratory was temporarily evacuated as a precaution.The customer left the windows open as the smell remained "very" strong after 3 days.
Additional Manufacturer Narrative
The field service engineer (fse) resolved the issue by replacing the power supply and fitting.The customer's power supply and fitting were submitted for investigation.The fitting was confirmed to be broken in half.The power supply was confirmed to show clear signs of charring.The power supply was fully disassembled.Signs of fluid intrusion were observed in the same area as the charring, indicating that the fluid entered from above the power supply and landed in this location.No other signs of fluid intrusion or charring were observed in other areas of the power supply.Manufacturing work instructions (mwi) related to the power supply assembly inside the benchmark ultra system were reviewed.The mwis include instructions for routing associated electrical cables through the opening on the splash panel and around the power supply.Images showing the associated cable routing while the affected power supply was still installed on the instrument at the customer site were requested, however, they were not available.The benchmark ultra system is designed to comply with applicable electrical safety requirements such as iec 61010-1 and iec 61010-2.This event was due to an electrical short in the power supply, which caused the instrument to shut down after the power supply failed; no further electrical damage occurred.The investigation did not identify a global trend for these products where a similar issue was observed.The investigation determined that the event was due to fluid leakage from the broken fitting.The investigation did not identify a systemic product issue.The issue was resolved by replacing the affected product.

• Brand Name: BENCHMARK ULTRA SYSTEM
• Common Device Name: SLIDE STAINER, AUTOMATED
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS INC.; 1910 e innovation park dr; tucson AZ 85755
• Manufacturer (Section G): VENTANA MEDICAL SYSTEMS INC.; 1910 e innovation park dr; tucson AZ 85755
• Manufacturer Contact: timothy blair ; 1080 us hwy 202 s; branchburg, NJ 08876 ; 9253534412
• MDR Report Key: 21774175
• Report Number: 2028492-2025-01017
• Device Sequence Number: 18208655
• Product Code: KPA
• UDI-Device Identifier: 04015630981052
• UDI-Public: 04015630981052
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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 Catalogue Number: 05342716001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown