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