FDA Adverse Event
Malfunction
Summary report: N
BOSS INSTRUMENTS
MDR report key: 24589563
·
Received March 13, 2026
Report
- Report Number
- 24589563
- Event Type
- Malfunction
- Date Received
- March 13, 2026
- Date of Event
- August 13, 2025
- Report Date
- February 27, 2026
- 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
SUCTION PORTION DID NOT WORK. A NEW HANDPIECE WAS OPENED TO COMPLETE THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 659153 | BOSS INSTRUMENTS | RETRACTOR, FIBEROPTIC | FDG | BOSS INSTRUMENTS, LTD | VSX233 | 2159001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Female | Other |