Device product
bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
Z-0500-2018
Product summary
- Event
- Event 78789
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45, 680 units
- Official record key
device-enforcement:Z-0500-2018
Official wording
Reason: The protective shield was retracted, and the blade was exposed.
Code information: (a) REF 370531; Batch numbers: 3185248 3191981 3193837 3199247 3201734 3204737 3206382 3208096 3211720 3213361 3214546 3217371 3219431 3222626 3225976 (b) REF 378233; Batch numbers: 3191985 3204382 3225442
Distribution pattern: Worldwide Distribution - US Nationwide and the countries of Italy, UK, Finland, Germany, Ireland, Turkey
Derived failure modes
-
Unknown
The protective shield was retracted, and the blade was exposed.