MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-25 for BARCO MDSC-8255 MNA K9307931, K9307932 manufactured by Barco Nv.
[125109993]
During minimally-invasive surgery the surgical display switched to standby and could not be reactivated immediately. Because the backup screen was not available (the screen was positioned behind the surgeon) the surgeon decided to switch from laparoscopy to open surgery. There was no malfunction in the display. The patient recovered well after the surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9613188-2018-00001 |
| MDR Report Key | 8004123 |
| Date Received | 2018-10-25 |
| Date of Report | 2018-10-24 |
| Date of Event | 2018-09-26 |
| Date Mfgr Received | 2018-09-27 |
| Date Added to Maude | 2018-10-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR LIEVEN DE WANDEL |
| Manufacturer Street | BENELUXPARK 21 |
| Manufacturer City | KORTRIJK, 8500 |
| Manufacturer Country | BE |
| Manufacturer Postal | 8500 |
| Manufacturer G1 | BARCO NV |
| Manufacturer Street | PRESIDENT KENNEDYPARK 35 |
| Manufacturer City | KORTRIJK, 8500 |
| Manufacturer Country | BE |
| Manufacturer Postal Code | 8500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BARCO |
| Generic Name | MDSC-8255 MNA |
| Product Code | KQM |
| Date Received | 2018-10-25 |
| Model Number | MDSC-8255 MNA |
| Catalog Number | K9307931, K9307932 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARCO NV |
| Manufacturer Address | PRESIDENT KENNEDYPARK 35 KORTRIJK, 8500 BE 8500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-25 |