MAUDE Adverse Event Report: BARCO NV BARCO; SURGICAL DISPLAY

Model Number	MDSC-8527
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Handling Problem (3265)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Cover for cable connections (plastic cover) fell when moving the monitor on the operating table during surgical preparation.Operating table unsterile longer operation and anesthesia time for the patient.Cover probably came loose during cleaning.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide updated fields and final investigation results.The customer has provided additional information from their investigation.The detachment of the display cover was caused by incorrect use of the arm on which the display was mounted.The handles provided for moving the display on the spring arm were not used.Instead, the monitor was gripped and moved by the reces or cable entry.The users were advised by the customer not to do this in the future.Additionally, cable covers were secured with cable ties.Additionally the customer confirmed that the event occurred before surgery and not during surgery.There was no additional anesthesia and no prolongation of the procedure.The patient was not harmed.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide updated fields and final investigation results.The customer has provided additional information from their investigation.The detachment of the display cover was caused by incorrect use of the arm on which the display was mounted.The handles provided for moving the display on the spring arm were not used.Instead, the monitor was gripped and moved by the reces or cable entry.The users were advised by the customer not to do this in the future.Additionally, cable covers were secured with cable ties.Additionally the customer confirmed that the event occurred before surgery and not during surgery.There was no addional anesthesia and no prolongation of the procedure.The patient was not harmed.

• 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: 18985050
• Report Number: 3004455125-2024-00014
• Device Sequence Number: 11480077
• Product Code: KQM
• UDI-Device Identifier: 05415334043312
• UDI-Public: 05415334043312
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 03/27/2024

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-8527
• Device Catalogue Number: K9352421
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 05/15/2024; 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2023
• 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