MAUDE Adverse Event Report: BARCO NV BARCO; SURGICAL DISPLAY

Model Number	MDSC-8532 NXF
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2026
Type of Reportable Event	Malfunction

• 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 S.R.L.; via saul banfi 1; saronno, varese 21047 ; IT 21047
• Manufacturer Contact: celien caerels ; president kennedypark 35; kortrijk, west-vlaanderen 8500 ; BE 8500
• MDR Report Key: 25763840
• Report Number: 3004455125-2026-00006
• Device Sequence Number: 9740912
• Product Code: KQM
• UDI-Device Identifier: 05415334042414
• UDI-Public: 05415334042414
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/09/2026

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: Other
• Device Model Number: MDSC-8532 NXF
• Device Catalogue Number: K9352422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 07/09/2026
• 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