FDA Adverse Event
Malfunction
Summary report: N
BVI BEAVER XSTAR SAFETY SLIT KNIFE
MDR report key: 23257498
·
Received October 9, 2025
Report
- Report Number
- MW5177132
- Event Type
- Malfunction
- Date Received
- October 9, 2025
- Date of Event
- September 25, 2025
- Report Date
- October 3, 2025
- Manufacturer
- BEAVER-VISITEC INTERNATIONAL, INC.
- Product Code
- HNN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
SILVER SPECKS WERE NOTED IN THE INCISION BY SURGEON AFTER INCISION WAS MADE BY A BVI BEAVER XSTAR SLIT KNIFE 2.4MM 45 DEGREE BEVEL UP REF 378224, LOT 6051110, EXP 04/03/2027.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301739 | BVI BEAVER XSTAR SAFETY SLIT KNIFE | KNIFE, OPHTHALMIC | HNN | BEAVER-VISITEC INTERNATIONAL, INC. | 6051110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |