MAUDE Adverse Event Report: BARCO NV BARCO; SURGICAL DISPLAY

Model Number	MDSC-8532 SSTF
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	06/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred during the weekend, when nobody was present.After the weekend, the user entered the room and noticed that the front filter had detached from the display and was broken on the floor.The event did not happen in the operating room but in the customer's experience center.One week earlier the customer had noticed that the front filter of the same display had partially come loose without detaching completely.Instead of taking the display out of service (as is prescribed in the instructions for use) the customer pushed back the front filter and continued to use the display.It is the very first time that we receive a complaint of a completely detached front filter.We have done extensive testing in our lab to reproduce this fault but could not reproduce it.We conclude that the event is solely caused by the manipulation of the user.
Event or Problem Description
On june 23, we received a complaint from a customer about a front filter detachment.After the weekend, the customer entered their demo room and noticed that the front filter (glass) had completely detached from the display, fallen down and shattered into pieces.There was nobody near the display at the time the glass had fallen.Nobody has seen the glass falling down.No injuries have been reported.One week earlier, the same customer had informed us that the front glass of the same display in the demo room had partly detached.It was still partially attached to the display and was not completely loose.Instead of taking the display out of service, as instructed in the instructions for use, the user pushed back the front glass.The event of partial detachment has no risk at all that it could cause or contribute to any harm whatsoever, if it would occur again.

• 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: 22519606
• Report Number: 3004455125-2025-00001
• Device Sequence Number: 20847614
• Product Code: KQM
• UDI-Device Identifier: 05415334042674
• UDI-Public: 05415334042674
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: Other
• Device Model Number: MDSC-8532 SSTF
• Device Catalogue Number: K9352402B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2024
• 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