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This product has been manufactured not to include latex.
Intended Use:
The Padlock Clip™ is indicated for use in flexible Endoscopy and for the compression of tissue in the gastrointestinal
tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs. The Padlock Clip™ is indicated for
clip placement within the gastrointestinal (GI) tract for the purpose of:
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Endoscopic marking of lesions
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Hemostasis for:
o
o
o
o
o
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Closure of GI tract luminal perforations <20mm that can be treated conservatively
Product Description:
The Padlock Clip™ defect closure system consists of a preloaded, radiopaque, Super Elastic NiTi (Nitinol) single use clip within a delivery
system. The Padlock Clip™ defect closure system is a onetime use: tissue approximation device.
The Padlock Clip™ defect closure system is mounted and secured at the distal tip on the outside surface of an Endoscopic Instrument
such as a Gastroscope and/or Colonoscope. The Padlock Clip™ is deployed using an independent hand control. The linking cable to the
hand control is not located within any instrument working channel.
The Padlock Clip™ defect closure system includes a central "tissue chamber" that resides on the distal end of the scope instrument tip.
Clinically efficacious tissue manipulation techniques may be used to pull target tissue into this "tissue chamber" to approximate a larger
volume of tissue than would otherwise be approximated by deploying the clip alone.
The Padlock Clip™ defect closure system is compatible with Endoscopic Instruments such as Gastroscopes and Colonoscopes with
distal tip outer diameters ranging from 9.5mm to 14mm.
Product codes are specific to fit an endoscopic instrument range as illustrated on the pouch label.
Warnings and Precautions:
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Do not attempt to reuse, reprocess, refurbish, remanufacture or resterilize this device. US Endoscopy did not design this device nor
is it intended to be reused, reprocessed, refurbished, remanufactured, or resterilized. Performing such activities on this disposable
medical device presents a safety risk to patients (i.e. compromised device integrity, cross-contamination, infection).
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The Padlock Clip™ defect closure system is supplied sterile.
o
Carefully examine unit to verify that neither the contents nor the package has been damaged in shipment and if damage is
evident, do not use this product and contact your local Product Specialist or Customer Service Representative.
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The Padlock Clip™ defect closure system is compatible with a wide range Gastroscopes and Colonoscopes.
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Consult product label.
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Check to ensure the distal tip size of the instrument is within 9.5mm to 14mm before mounting.
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Operation of this instrument is based on the assumption that open surgery is possible as an emergency measure if the clip
does not release completely from the delivery system or if any other unexpected circumstance takes place.
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The Safety Cap on the Padlock Clip™ defect closure system is to ensure safe handling during connection and attachment of the
Padlock Clip™ defect closure system to the endoscopic instrument.
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Do not remove the Safety Cap until the Padlock Clip™ defect closure system is positioned, mounted and secured to the
endoscopic instrument.
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Care should be taken after removal of the safety cap.
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Hands and fingers are to be kept clear from the delivery system distal tip area so that an accidental release of the
clip does not result in personal injury to medical staff.
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Once the Safety Cap is removed, keep Hands and Fingers clear from the delivery system distal tip so that an accidental
release of the clip does not result in personal injury.
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Possible Complications:
o
Lesions located in the esophagus and the lesser curvature of the stomach may be difficult to treat with a forward viewing
endoscope.
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Clipping hard or severely fibrotic lesions to achieve hemostasis may be more difficult.
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Re-bleeding may occur if clip detaches within 24 hours.
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The use of clips in the presence of bacterial contamination may increase or prolong infection.
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Although rates of occurrence are low, recurrent bleeding, ineffective clipping or endoscopic complications could result in
the need for surgery.
732380 Rev. B
Mucosal/Submucosal defects
Bleeding Ulcers
Arteries <2mm
Polyps <1.5cm in diameter
Diverticula in the Colon
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