MAUDE Adverse Event Report: BARCO NV BARCO; SURGICAL DISPLAY

Model Number MDSC-8231 12G

Device Problems No Display/Image (1183); Electromagnetic Interference (1194)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/29/2024

Event Type  Injury  

Event Description

Dr advised that he had a patient suffer tur syndrome during a turbt (resection of bladder tumour) as a result of losing vision with the barco monitor.Dr needed to revert back to the old stack which added time to the procedure.The procedure took longer than intended as a result of the equipment issue, and therefore the patient suffered tur syndrome.

• Brand Name: BARCO
• Type of Device: 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: 18986191
• MDR Text Key: 338701916
• Report Number: 3004455125-2024-00015
• Device Sequence Number: 1
• Product Code: KQM
• UDI-Device Identifier: 05415334026568
• UDI-Public: 05415334026568
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MDSC-8231 12G
• Device Catalogue Number: K9352051
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening