Ethicon Inc

Clip Applier 333mm x 10mm Yellow Large

LIGACLIP Dismantlable Endoscope Appliers

253 Pages

Warnings and Precautions • Consult medical literature relative to techniques, complications, and hazards prior to performance of any minimally invasive procedure involving the use of metallic clips. • Minimally invasive instruments may vary in diameter from manufacturer to manufacturer. When minimally invasive instruments and accessories from different manufacturers are employed together during a procedure, verify compatibility prior to initiation of procedure. • A thorough understanding of the principles and techniques involved in laparoscopic laser and electrosurgical procedures is essential to avoid shock and burn hazards to both patient and medical personnel and damage to the device or other medical instruments. Ensure that electrical isolation or grounding is not compromised. • Ensure that the clip is the correct size for the vessel or tubular structure being ligated. • Upon each clip application, fully squeeze the handle of the instrument until it comes to a stop. • Failure to fully squeeze the handle can result in improper formation of clips, and therefore, unsatisfactory ligation of tissue. • Ensure that each clip has been securely and completely positioned around the tissue being ligated. • The condition of the LIGACLIP™ Dismantlable Endoscopic Applier, the closure force exerted by the surgeon, the thickness of the tissue to be ligated, and the nature of the clip itself are all critical to the performance of any ligating clip. • As with any ligating method, inspect each ligation site following placement of the clip to ensure that the clip has been satisfactorily placed. • Do not close the jaws of the instrument over other surgical instruments.  • Do not use scouring pads, abrasive cleaners, or a steel wire brush, which may cause damage to the surfaces of the device. • Only non-silicone, water-based lubricants should be used. Silicone or oil-based lubricants should not be used because this may compromise the ability to sterilize the device. • All surgical instruments are subject to a certain degree of wear and tear caused by normal use. Because of this they should undergo regular careful visual inspection before use. Defective instruments (instruments which do not function properly, are subjected to heavy use, have fissures or pitting indicating corrosion, etc.) are associated with a high degree of risk to the patient and hence should not be used. • Instruments or devices which come into contact with bodily fluids may require special disposal handling to prevent biological contamination. Disposal of all medical device instruments and accessories should be performed according to local requirements and regulations. • Improper reprocessing or resterilization or maintenance may compromise the functional performance of the device or lead to device failure which in turn may result in patient injury or illness. • Improper reprocessing or resterilization of reusable devices may create a risk of contamination or cause infection or crossinfection, including, but not limited to, the transmission of infectious diseases. Contamination may lead to injury, illness, or death. Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the local competent authority of the country in which the user and/or patient is established.  Instructions for Device Processing Table of Contents for Device Processing: I. How Supplied  • Appliers in disrepair should not be used. The use of such appliers could result in inadequate function of the clip.  II.  • Do not lubricate device after sterilization, as this may compromise sterility of the device.  IV. General Cleaning Information  • To minimize the chance of corrosion, do not use saline for cleaning. • Follow the instructions and warnings issued by the suppliers of any cleaning and disinfection agents and equipment used. Avoid exposing devices to hypochlorite solutions, as these will promote corrosion. Do not use cleaning agents with chlorine or chloride as they are corrosive.  2023-02-14 15:19:13  Initial Treatment at the Point of Use  III. Containment and Transportation V.  Cleaning and Disinfection Processing Options a. Option 1 – Validated Automated Process using Mild Alkaline Detergent Chemistries and Thermal Disinfection b. Option 2 – Validated Automated Process using Enzymatic and Neutral pH Detergent Chemistries and Thermal Disinfection  This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.  4 of 253
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