Device product
BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
Z-2649-2016
Product summary
- Event
- Event 74790
- Status
- Terminated
- Classification
- Class II
- Quantity
- 95
- Official record key
device-enforcement:Z-2649-2016
Official wording
Reason: The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.
Code information: Lot 0316D.
Distribution pattern: Worldwide Distribution - US Nationwide in the states of: MD, GA, MO and FL and the country of Finland.
Derived failure modes
-
Unknown
The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.