FDA Adverse Event
Injury
Summary report: N
BARCO
MDR report key: 18986191
·
Received March 27, 2024
Report
- Report Number
- 3004455125-2024-00015
- Event Type
- Injury
- Date Received
- March 27, 2024
- Date of Event
- February 29, 2024
- Report Date
- February 27, 2024
- Manufacturer
- BARCO NV
- Product Code
- KQM
- UDI-DI
- 05415334026568
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1985164 | BARCO | SURGICAL DISPLAY | KQM | BARCO NV | MDSC-8231 12G | 05415334026568 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Life Threatening |