Inhaltsverzeichnis
Werbung
ENGLISH
EXPRESSEW
Flexible Suture Passer
DESCRIPTION
The EXPRESSEW
when utilized with the EXPRESSEW
EXPRESSEW III Suture Needle, is an orthopedic
manual surgical instrument designed to pass 2-0 to
#2 braided surgical sutures through tissue in either
arthroscopic or open surgery. The Flexible Suture
Passer has a diameter of less than 5mm. The
needle is retractable. The EXPRESSEW III Flexible
Suture Passer is to be used exclusively with the
DePuy Mitek Flexible Suture Passer Needle.
INDICATION FOR USE
The EXPRESSEW III Flexible Suture Passer is
indicated for passing suture through tissue in
orthopedic surgery.
CONTRAINDICATIONS
Device not to be used on bone or similar
hard tissue.
WARNINGS
Whether used arthroscopically or in open surgery,
the EXPRESSEW III Flexible Suture Passer must
be used under direct visualization.
The EXPRESSEW III Suture Needle is for
SINGLE USE ONLY. DO NOT RESTERILIZE OR
REUSE the suture needle. Reuse of the needle
may cause the needle to fatigue and break, which
could cause patient injury.
This product is for single use only. It has not been
designed to be reused/re-sterilized. Reprocessing
may lead to changes in material characteristics
such as corrosion and dulled edges, which may
impact the strength of the device and compromise
performance. Reprocessing of single-use devices
can also cause cross-contamination leading to
patient infection. These risks may potentially affect
patient safety.
PRECAUTIONS
• This device should be used only by physicians
with a thorough understanding of orthopedic
procedures.
• Do not use the EXPRESSEW III Flexible Suture
Passer through a cannula less than 5mm in
diameter.
PREPARATION FOR USE
Read the Instructions For Use in its entirety prior to
use of the devices.
1. Inspect for damage to product or sterile barrier
in the case of the disposable needle. Do not
use if product is damaged or sterile barrier is
compromised.
2. Inspect the EXPRESSEW III Flexible Suture
Passer prior to use to ensure proper
mechanical function.
3. Steam sterilize the Flexible Suture Passer
according to the instructions in the STERILIZA-
TION section in this Instructions For Use.
III
®
III Flexible Suture Passer,
®
2
II or
®
Werbung
Inhaltsverzeichnis
