MAUDE Adverse Event Report: BARCO NV BARCO; SURGICAL DISPLAY

Model Number	MDSC-8232
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There have been similar complaints in which we noticed that the customer had not connected the potential equalization (poag) connector.
Event or Problem Description
During turp surgery screen 1 turned off/blacked out.Surgeon unable to see - had to pause surgery while waiting for screen 2 to be placed in position before continuing.Nursing team turned screen 1 on and off to reset, screen 1 went back to image.Screen 2 also turned off/went black so screen 1 repositioned for surgeon again to use.
Additional Manufacturer Narrative
There have been similar complaints in which we noticed that the customer had not connected the potential equilization (poag) connector.There was an error in the dates of occurrence and date of report in initial report.This is a correction.
Event or Problem Description
During turp surgery screen 1 turned off/blacked out.Surgeon unable to see - had to pause surgery while waiting for screen 2 to be placed in position before continuing.Nursing team turned screen 1 on and off to reset, screen 1 went back to image.Screen 2 also turned off/went black so screen 1 repositioned for surgeon again to use.

• 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: 24639768
• Report Number: 3004455125-2026-00001
• Device Sequence Number: 13313976
• Product Code: KQM
• UDI-Device Identifier: 05415334026513
• UDI-Public: 05415334026513
• 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,Followup
• Report Date (Section B): 03/19/2026

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-8232
• Device Catalogue Number: K9352185
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 02/25/2026; Not provided
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 03/19/2026; 06/17/2026
• 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