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

Catalog Number	05342716001
Medical Device Problem Codes	Degraded (1153); Device Emits Odor (1425)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2028492-2022-00014
• Device Sequence Number: 17694254
• Product Code: KPA
• UDI-Device Identifier: 04015630981052
• UDI-Public: 04015630981052
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: 510K 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 12/15/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2028492-01-10-2022-001-C
• Patient Sequence Number: 1
• Patient Sex: Unknown