pulse sequence).
In non-clinical testing, the image artifact caused by this
device extends approximately 25-mm from this device
when imaged using a gradient echo pulse sequence and a
3-Tesla MR system.
NOTE: Do not take the clip applier into the MR
environment.
The clip applier contains material which has
been determined to be MR Unsafe.
12. Caution
Use of this product is restricted to surgeons with proper
training in the use of this product.
13. Defects and Adverse Events
1) Serious adverse events
・ Displacement of the clip (slippage)
・ Ejection of the clip from clip applier
・ Breakage of the clip
-12-