FDA Adverse Event
Malfunction
Summary report: N
BOSS MINI VERSALIGHT
MDR report key: 21890335
·
Received April 23, 2025
Report
- Report Number
- 21890335
- Event Type
- Malfunction
- Date Received
- April 23, 2025
- Date of Event
- March 3, 2025
- Report Date
- April 21, 2025
- Manufacturer
- BOSS INSTRUMENTS, LTD
- Product Code
- FDG
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- WA
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
LEAK IN THE MID TIP WHEN IRRIGATING. OPENED A NEW MINI-VERSA LIGHT PRODUCT TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 726643 | BOSS MINI VERSALIGHT | RETRACTOR, FIBEROPTIC | FDG | BOSS INSTRUMENTS, LTD | 2045001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Female |