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

Catalog Number 05342716001

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2023

Event Type  malfunction  

Event Description

The customer reported an issue with the cover of the benchmark ultra stainer module.The operator was loading reagents and the cover reportedly fell onto the operator's wrist.

Manufacturer Narrative

The reason the cover reportedly fell is being investigated.

Manufacturer Narrative

The lid counterbalance and images of it were requested for investigation, but these could not be provided.The investigation determined the issue is consistent with overextension of the hinge during the use of the instrument.Mechanical stops on the hinge of the lid control how far the hinge will open (85 degrees plus or minus 5 degrees).Opening or forcing the lid past the typical 85 degrees increases the chances of the pin and connector bushing detaching, allowing the compression spring assembly to fall out of the hinge.

• Brand Name: BENCHMARK ULTRA
• Type of Device: 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
• MDR Report Key: 18507214
• MDR Text Key: 333322038
• Report Number: 2028492-2024-00130
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 04015630981052
• UDI-Public: 04015630981052
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05342716001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1