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	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Monitors are randomly changing channels without anyone touching them.This issue occurs typically towards the end of the day and will happen randomly in the middle of cases while the surgeons are operating.It usually only happens to one screen at a time, for example 15 minutes ago the monitor the surgeon was using in the middle of a turp went black.Nobody was touching the screen or the console.We swapped the monitors around to continue the procedure and when i examined the black monitor, i saw that it had swapped itself to the 2d channel without anybody touching it.

• 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): FIMI 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: 20493628
• Report Number: 3004455125-2024-00020
• Device Sequence Number: 17044331
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 10/21/2024

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: 09/24/2024
• Initial Report FDA Received Date: 10/21/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown