LeMaitre AnastoClip Instructions D'utilisation page 2

AnastoClip® Universal Clip Remover
(Model Number 4001-04, 4013-01)
English — Instructions for Use
BEFORE USING PRODUCT, READ THE FOLLOWING
INFORMATION THOROUGHLY.
Indications
The AnastoClip Universal Clip Remover is only intended to remove
AnastoClip® implantable clips (when necessary) during general
surgery, vascular surgery, and neurosurgery.
The AnastoClip Universal Clip Remover is available in two (2)
lengths.
Model
Number
A.) 4001-04
B.) 4013-01
NOTE: Usable Length on the Remover refers to the distance between
the tips and the midpoint of the serrated region on the handle.
Instructions For Use
To remove a misplaced clip, place the
AnastoClip Remover underneath and through
the apex of the already placed clip. Squeeze
the handles of the AnastoClip Remover
together. This process will open the clip and
allow for the clip to be removed from the
tissue.
WARNING
The AnastoClip Remover is provided STERILE and is intended for
use in a SINGLE procedure only.
Complications
• Infection
• Pain/swelling
• Tissue damage
• Blood leakage
• Hemorrhage
• Intimal dissection
• Anastomosis rupture
• Dehiscence
• Necrosis
• Nerve injury
• Intimal hyperplasia
• Cerebrospinal fluid (CSF) leak
• Neuropathic pain
• Spinal infarction
Resterilization/ Re-use
This device is single-use only. Do not reuse, reprocess, or
re-sterilize. The cleanliness and sterility of the re-processed
device cannot be assured. Reuse of the device may lead to cross
contamination, infection, or patient death. The performance
characteristics of the devices may be compromised due to
reprocessing or re-sterilization since the devices were only
2
Usable
Length
4" (10cm)
6" (15cm)
A
Width at rest
>24mm (.9")
>18mm (.7")
B
Application
Shallow, wide
access
Deep, narrow
access