MAUDE Adverse Event Report: BARCO NV BARCO; SURGICAL DISPLAY

Model Number	MDSC-8231
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The display went blank twice during a turp procedure.The staff was unable to reboot it.There was another screen available on a different stack.The procedure was extended because of the issue and was completed using the screen on the other stack.
Additional Manufacturer Narrative
There have been similar complaints in which we noticed that the customer had not connected the potential equalization (poag) connector.In this issue our service engineers have detected that the poag was connected, but not in the correct way.We believe that this has caused the signal loss.
Additional Manufacturer Narrative
It has been confirmed that the poag was not connected, despite barco's instruction to do so.We have reached out to the customer and have been provided with some additional information: - this was only happening at this one hospital in one particular theatre, that is being used with diathermy tools.- it happens on any replacement mdsc-8231 mna monitor that is in this theatre.- it always happens at the end of the day, between 4pm and 5pm.- currently they have removed these monitors from this room and are using the olympus monitors on the diathermy stack for these procedures.The affected device was not returned to barco.

• Brand Name: BARCO
• Common Device Name: SURGICAL DISPLAY
• Manufacturer (Section D): BARCO NV; president kennedypark 35; kortrijk, west-vlaanderen 8500 ; BE 8500
• Manufacturer (Section G): BARCO SRL; via saul banfi, 1; saronno, varese 21047 ; IT 21047
• Manufacturer Contact: lieven de wandel ; president kennedypark 35; kortrijk, west-vlaanderen 8500 ; BE 8500
• MDR Report Key: 23509387
• Report Number: 3004455125-2025-00003
• Device Sequence Number: 9954952
• Product Code: KQM
• UDI-Device Identifier: 05415334001817
• UDI-Public: 05415334001817
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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 Model Number: MDSC-8231
• Device Catalogue Number: K9307927
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown