MAUDE Adverse Event Report: BARCO NV BARCO; MDSC-8231

Model Number	MDSC-8231 12G
Medical Device Problem Codes	No Display/Image (1183); Electromagnetic Interference (1194)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We were informed about a hospital experiencing 2 issues.With both of olympus towers going down today it is affecting service delivery of urology.The hospital's urocams and ureteroscopes only fit into this tower (and on pendant in or5 if orthopaedics is not occupying the room) recently the cable was changed, however intermittently it has turned off mid procedure.The standby light alternates from red to green and now the monitor will not turn on at all.The patient was not affected.There was diathermy used during the case.The leads were separated to minimise interference.The unit was not disconnected for 5 mins.

• Brand Name: BARCO
• Common Device Name: MDSC-8231
• 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: 19738619
• Report Number: 3004455125-2024-00016
• Device Sequence Number: 7991683
• Product Code: KQM
• UDI-Device Identifier: 05415334001367
• UDI-Public: 05415334001367
• 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: Foreign
• Initial Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 07/15/2024

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-8231 12G
• Device Catalogue Number: K9352051
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 07/15/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown