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

Catalog Number	05342716001
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) identified that the mechanical stop, designed to limit the lid opening to (85°±5°), was found to be deformed and not properly secured.Over repeated opening cycles, this mechanical stop likely shifted and deformed, eventually allowing the lid to overextend beyond 90°.This overextension caused eventual detachment of the lid counterbalance assembly.The fse replaced the failed lid counterbalance assembly and confirmed the instrument is operating as intended.The investigation determined that the service actions resolved the issue.
Event or Problem Description
The customer reported an issue with the cover of the benchmark ultra system.It was reported that while opening the instrument hood, the lid counterbalance assembly became detached and fell into five pieces.The lid subsequently fell, pinching the operator's thumb.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250 ; 9253534412
• MDR Report Key: 24689993
• Report Number: 2028492-2026-01092
• Device Sequence Number: 13188252
• Product Code: KPA
• UDI-Device Identifier: 04015630981052
• UDI-Public: 04015630981052
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 03/25/2026

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 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: 03/09/2026
• Initial Report FDA Received Date: 03/25/2026
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White