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

Catalog Number 05342716001

Device Problems Degraded (1153); Device Emits Odor (1425)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2022

Event Type  malfunction  

Manufacturer Narrative

An investigation was initiated and confirmed that fluid migrated down tubing or cabling to the j1 connector of the general purpose input output (gpio) board.As a result, the j1 connector and plug of the pcb gpio assembly svc was compromised leading to an electrical short.Additional analysis and investigation is ongoing to determine the root cause(s) of fluid leaks.Consignees have been notified.Local field service engineers will contact the customers and perform specific service actions during a site visit, such as, inspecting all devices for any signs of current and/or past fluid leaks, cracks, or clogging and clean & replace any gpio boards that have these signs.Additionally, the field service engineers will rearrange cables that plug into port j1 of the left as well as right gpio boards of the instruments, to introduce a drip loop to each cable in order to redirect fluids away from the boards at j1 position, to help mitigate the issue.

Event Description

A customer from japan alleged that a benchmark ultra device suddenly shut down during a run and emitted a burnt odor.No harm or injury alleged.

• Brand Name: BENCHMARK ULTRA STAINER MODULE
• Type of Device: SLIDE STAINER, AUTOMATED
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; tuscon AZ 85755
• Manufacturer (Section G): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; tuscon AZ 85755
• Manufacturer Contact: timothy blair ; 1080 us hwy 202 s; building 500, room: 3530; branchburg, NJ 08876 ; 9253534412
• MDR Report Key: 15992315
• MDR Text Key: 308281843
• Report Number: 2028492-2022-00014
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 04015630981052
• UDI-Public: 04015630981052
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: 510K 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05342716001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2022
• 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
• Removal/Correction Number: 2028492-01-10-2022-001-C
• Patient Sequence Number: 1