Device product
PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a neutral plasma surgery system that is designed for cutting and coagulation in open surgery and laparoscopic surgery.
Z-1794-2012
Product summary
- Event
- Event 61951
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36 units
- Official record key
device-enforcement:Z-1794-2012
Official wording
Reason: Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible leakage of a very small drop of distilled water coolant from the handpiece in use.
Code information: Lot Number 40041, exp. date February 2015 and Lot Number 40043, exp. date February 2015
Distribution pattern: Worldwide distribution: USA (nationwide) including states of: CA and NY; and country of: United Kingdom.
Derived failure modes
-
Unknown
Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible leakage of a very small drop of distilled water coolant from the handpiece in use.