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

Catalog Number 06468373001

Device Problem Fluid/Blood Leak (1250)

Patient Problem Fall (1848)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

Full name - (b)(6).A customer in (b)(6) reported that a lab technician slipped and injured their shoulder and had to undergo interventional surgery as a result of a leakage from spigot that the user forgot to properly close from a benchmark special stains stainer module.Per customer site's internal investigation, this was a human error.(b)(4).

Event Description

A customer in (b)(6) reported that a lab technician slipped and injured their shoulder and had to undergo interventional surgery as a result of a leakage from spigot that the user forgot to properly close from a benchmark special stains stainer module.Per additional information, there was leakage from a storage container of bulk reagents as a result of the spigot/tap not closed or overturned inappropriately.Per the operator's manual - place mats around the instrument to avoid risk of slipping in the event of reagent spills or leaks.Per customer site's internal investigation, this was a human error.

Manufacturer Narrative

An investigation was performed to evaluate the customer issue.Although the actual leak was never seen, it most likely originated from a benchmark special stains carboy spigot that was not shut off properly.There was no evidence of the source of leak and it does not seem likely that the alleged device caused or contributed to the technician's injury.There is no evidence the adverse event was caused by a roche product.(b)(4).

• Brand Name: BENCHMARK SPECIAL STAINS SYSTEM
• Type of Device: SLIDE STAINER, AUTOMATED
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS INC.; 1910 e innovation park dr; tucson AZ 85755
• Manufacturer Contact: stacie-ann creighton ; 1910 east innovation park dr; na; tuscon, AZ 85755 ; 9082537112
• MDR Report Key: 12746472
• MDR Text Key: 279907730
• Report Number: 2028492-2021-00008
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 06468373001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female