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

Catalog Number	05342716001
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The laboratory reported that due to the fall, the employee broke her leg which was reportedly treated in the emergency department on the day of the incident.According to the laboratory, the employee was presumably sent home after seeing a physician.The employee reportedly had an orthopedic follow-up on (b)(6) 2023.The laboratory manager was reluctant to provide any further information and stated that this was not the fault of a roche product.According to the investigation at the site, the spigot on the waste carboy was not properly closed at the time of the incident, allowing waste fluids to leak onto the floor near the instrument.The facility felt that it may have been accidentally bumped open with the movement of the carboy in and out of the instrument as they were able to confirm that the spigot could fully close with no leakage.The lab manager confirmed that this event was due to a procedural issue in their laboratory.No parts were repaired or replaced as there was no evidence of a roche product malfunction.The managing waste containers section of the instrument user guide instructs the user to "make sure that the spigot handle is in the off position (the word "off" on the handle should be facing the front).".
Event or Problem Description
We received information that an operator suffered an injury from slipping on liquid that had leaked from a waste carboy of the benchmark ultra stainer module.

• Brand Name: BENCHMARK ULTRA
• 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
• MDR Report Key: 18138985
• Report Number: 2028492-2023-03611
• Device Sequence Number: 6560511
• Product Code: KPA
• UDI-Device Identifier: 04015630981052
• UDI-Public: 04015630981052
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: 510K EXEMPTN
• 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
• Report Date (Section B): 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 05342716001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 11/15/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female