apollo endosurgery X-Tack Gebrauchsanweisung Seite 2

Single use only. Disposable. Do not resterilize. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Patent Pending.
DISCLAIMER OF WARRANTY AND LIMITATION OF REMEDY
THERE IS NO EXPRESS OR IMPLIED WARRANTY, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE, ON THE APOLLO ENDOSURGERY, INC. PRODUCT(S) DESCRIBED IN THIS PUBLICATION. TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, APOLLO
ENDOSURGERY, INC. DISCLAIMS ALL LIABILITY FOR ANY INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, REGARDLESS OF WHETHER SUCH LIABILITY
IS BASED ON CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY, PRODUCTS LIABILITY OR OTHERWISE. THE SOLE AND ENTIRE MAXIMUM LIABILITY OF APOLLO
ENDOSURGERY, INC., FOR ANY REASON, AND BUYER'S SOLE AND EXCLUSIVE REMEDY FOR ANY CAUSE WHATSOEVER, SHALL BE LIMITED TO THE AMOUNT PAID BY THE
CUSTOMER FOR THE PARTICULAR ITEMS PURCHASED. NO PERSON HAS THE AUTHORITY TO BIND APOLLO ENDOSURGERY, INC. TO ANY REPRESENTATION OR WARRANTY
EXCEPT AS SPECIFICALLY SET FORTH HEREIN. DESCRIPTIONS OR SPECIFICATIONS IN APOLLO ENDOSURGERY, INC PRINTED MATTER, INCLUDING THIS PUBLICATION, ARE
MEANT SOLELY TO GENERALLY DESCRIBE THE PRODUCT AT THE TIME OF MANUFACTURE AND DO NOT CONSTITUTE ANY EXPRESS WARRANTIES OR RECOMMENDATIONS
FOR USE OF THE PRODUCT IN SPECIFIC CIRCUMSTANCES. APOLLO ENDOSURGERY, INC. EXPRESSLY DISCLAIMS ANY AND ALL LIABILITY, INCLUDING ALL LIABILITY FOR
ANY DIRECT, INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, RESULTING FROM REUSE OF THE PRODUCT.
Table of Symbols
Description
Consult Electronic Instructions
for Use
Do Not Re-use
Sterilized Using Ethylene Oxide
Reference Number
Medical Device
Unique Device Identification
For Use with
MR Conditional
Intended Use
The X-Tack™ System is intended for approximation
of soft tissue in minimally invasive gastroenterology
procedures (e.g. closure and healing of ESD/EMR sites,
and closing of fistula, perforation or leaks).
The X-Tack™ System is not intended for hemostasis of
acute bleeding ulcers.
Clinical Benefit
When used to close ESD/EMR defects it is intended to
reduce the risk of delayed bleeding or perforation. When
used to close a fistula, perforation or leak, it is typically
intended to prevent contents of the gastrointestinal
tract from exiting the tract and causing sepsis.
Summary of Safety and Clinical Performance
The Summary of Safety and Clinical Performance
document, as required by the European Medical Device
Regulation, is located at https://ec.europa.eu/tools/
eudamed
Contraindications
Contraindications include those specific to use of
an endoscopic tacking system, and any endoscopic
procedure, which may include, but not limited to, the
following:
- This system is not for use where endoscopic
techniques are contraindicated.
- This system is not for use with malignant tissue.
Information To Be Provided to Patient
The X-Tack™ System comes with a patient implant card
that includes MRI Safety Information. This should be
provided to the patient.
Description
Symbol
Manufacturer
Caution: Federal law (USA) restricts this
device to sale by or on the order of a
physician
Date of Manufacture
Do Not Resterilize
Caution, consult accompanying
documents
Single Sterile Barrier System.
UDI
Sterilized by Ethylene Oxide
Gastric Icon
Global Trade Item Number
Warnings
- The device should not be used to treat acutely
bleeding ulcers, ulcers with stigmata of recent
bleeding or any ulcers with a visible vessel.
- X-Tack utilizes a 3-0 polypropylene suture with a
nominal tensile force of approximately 1.5 lb. If the
force applied to the suture exceeds that, the suture
may break. If the suture breaks, cut the suture using
endoscopic scissors and leave the deployed Helix
Tacks in place. Closure can be performed using
another X-Tack device or an alternative closure
device.
- If a Helix Tack is not fully embedded into the muscle
layer, it may be pulled free from the tissue when
tension is applied to the suture. If this happens,
continue to place the remaining Helix Tacks and then
cinch in the usual procedure. Evaluate the integrity
of the closure. If needed, supplemental fixation
may be applied using another X-Tack device or an
alternative device.
- Do not retract the X-Tack device into or through the
scope while a Helix Tack is present on the distal
end. This can prematurely disengage the Helix Tack
from the coil catheter. If this does happen, withdraw
the X-Tack and continue with the next Helix Tack.
Complete the closure in the normal process with
the remaining Helix Tacks embedded in the tissue.
The detached Helix Tack will be on the suture but not
contributing to the closure. Evaluate the integrity of
the closure. If needed, supplemental fixation may be
applied using another X-Tack device or an alternative
device.
Description
Symbol
Use By
Lot Number
Do not use if package is damaged
Authorized Representative in the
European Community
Contains Hazardous Substance
Contents
Colonic Icon
- If a Helix Tack disengages while in the scope and
becomes stuck in the channel liner, first try to push
the tack down the channel with the coil catheter. If
this cannot be done, remove the X-Tack catheter and
channel liner, leaving the suture in place. Cinch the
construct if Helix Tacks have already been placed in
tissue. Evaluate the integrity of the closure. If needed,
supplemental fixation may be applied using another
X-Tack device or an alternative device.
- Do not use a device where the integrity of the sterile
packaging has been compromised or if the device
appears damaged.
- Only physicians possessing sufficient skill and
experience in similar or the same techniques should
perform endoscopic procedures.
- Contact of electrosurgical components with other
components may result in injury to the patient and/
or operator as well as damage to the device and/or
endoscope.
- Verify compatibility of endoscope size, endoscopic
instruments and accessories and ensure performance
is not compromised.
- Ensure endoscope is clean, dry, and free of lubricants
prior to device installation.
- Ensure all endoscopic scopes, including scope
channels, are in good working condition prior to use.
- Suction operation through endoscope may be
significantly reduced when the scope channel liner is
in proper position.
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