Taiwan Surgical Corporation

 Disposable Clip Applier:

1. PRODUCT DESCRIPTION

   1. The 10mm Disposable Clip Applier ML / L contains 20 titanium clips in total. Titanium clip size is 5.5 x 9.0 mm (ML) or 5.5 x 11 mm (L). The applier is designed for introduction and use through all applicably sized trocar sleeve, or larger sized trocar sleeve with the use of a fitted converter.

2. INTENDED USE

   1. The use of the product is indicated in endoscopic procedures, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula for the purpose of ligating vessels and tubular structures.

3. CONTRAINDICATIONS

   1. Do not apply to contraceptive tubal occlusion, but might be used to achieve hemostasis following transection of the fallopian tube.

   2. Do not use the clip applier on the renal artery, iliac artery or other vessels where metal ligating clips could not be used normally.

4. WARNINGS AND PRECAUTIONS

   1. When inserting or removing the clip applier through the applicable size trocar sleeve, or larger sized sleeve, BE SURE THAT A CLIP OCCLUDE THE VESSEL WELL TO AVOID THE OPEN CLIP DROPPING IN THE BODY.

   2. Before squeezing the handle to place a clip, please be sure that it will be positioned free of other clips or other obstructions. Firing a clip over a clip might lead to bleeding, lack of hemostasis and/or destroy the jaws.

   3. Please be sure that the tissue to be occluded fits completely within the confines of the clip to avoid bleeding and leakage.

   4. WHEN FIRING THE DEVICE, PRESS THE HANDLE FIRMLY AS FAR AS IT WILL GO. Failure to squeeze the handle completely can lead to clip malformation and bleeding and/or leakage.

   5. Please do check all clips to confirm that none has been applied to another clip or obstruction and that hemostasis or occlusion has been made. If minor bleeding and/or leakage appears, electrocautery or manual sutures could be used to ensure hemostasis.

   6. When transecting an occluded structure, please leave enough margin of distal tissue to reduce the possibility of clip dislodgement. Bleeding and/or leakage could happen due to dislodgement of a clip.

   7. Endoscopic surgery should be performed only by physicians who have professional training and familiarity with endoscopic techniques. Prior to the performance of any endoscopic procedures, please consult the medical literature relevant to techniques, complications, and hazards.

   8. Please do not twist the jaws excessively or try to lift excessive tissue when firing the device.

   9. Please do not place an empty jaw or load a clip into the device while the jaw is around the tissue.

   10. PLEASE DO NOT USE THE DEVICE FOR DISSECTING TISSUE.

   11. STORE AT ROOM TEMPERATURE. AVOID PROLONGED EXPOSURE TO ELEVATED TEMPERATURES.

   12. DO NOT EXPOSE TO TEMPERATURES ABOVE 130°F, (54°C)

   13. If need to use endoscopy device from different companies in the same surgical procedure, please verify its compatibility before surgery. 

   14. The device has sterilized and is for single use, do not reuse and resterilize. Do not use if the package has been damaged or opened. Reuse or resterilize the clip applier may result in clip malfunction and infection of patients.

   15. This device is obtainable only on a physician's prescription.

   16. It should be noted the magnetic fields influences when using this device.

   17. The titanium clips may be implanted for a while or permanently. Biocompatibility testing has been performed to a level appropriate for permanent implant on titanium clips with no adverse effects noted.

   18. The device is MR conditional. Caution should be exercised when utilizing electrosurgical techniques such as electrocautery or electrocoagulation in the vicinity of any metallic clip. Inadvertent contact with a metallic clip by the energized electrosurgical device may cause unintentional cauterization or electrocoagulation at or around the clip site which may cause necrosis of the affected tissue. Dislodgement of the clip may occur, resulting in loss of hemostasis or leakage.

5. OPERATION NOTE

   1. When inserting or removing the clip applier through the trocar sleeve, please be sure that no clip is loaded in the jaw.

   2. The shaft is 360° rotatable in either direction. Please adjust the jaw for maximum visibility by turning the rotation knob.

   3. Before placing the jaw around the vessel or structure to be occluded, please squeeze the handle gently to fire.

   4. Place the jaw around the vessel or structure to be occluded, please be sure that the vessel or structure fits completely within the confines of the jaw, and close the clip on the vessel or structure.

   5. Release the handle to disengage the clip and remove the applier from the vessel or structure. Repeat the action above for subsequent application.

   6. When no clip is left in the applier, a yellow bar appeared in the window of jaw and clip indicator window shown ”0” means that the clip applier is empty of clips. The jaw must not contain any open clip when removing the shaft from the trocar sleeve.

   7. The sequence of closure.

   8. If desired, the clip applier could be used to secure a catheter for cholangiography. At a point during the closure, the handle is released to allow the clip being remained in the cystic duct. By releasing pressure on the handle, the clip is released from the jaw.