Johnson & Johnson ETHICON LAPRA-TY Suture Applier - User Manual

LAPRA-TY® Suture Applier
LAPRA-TY® Suture Clips are not intended for use in clinical situations that require the use of suture material other than sizes 2-0, 3-0
or 4-0 Coated VICRYL® (polyglactin 910) Suture. Failure to use indicated suture type and size may result in insuicient clip security.
For all product details, including a complete list of warnings and precautions, please reference the Instructions for Use
Optimized Device Performance Guide
S:10.5”
S:8”
T:11”
T:8.5”
B:11.25”
B:8.75”
ETHI18LINK0755_Endomac_LAPRA_ODP_r6.indd 1 10/1/18 12:36 PM

Summary

LAPRA-TY Suture Applier Guide

Grasping the Applier

Grasp the applier handle and insert jaws into the cartridge slot, ensuring tips are perpendicular to the cartridge surface.

Placing Suture Clip

Place clip 5mm from suture cut end. Avoid placing suture near the latch for security.

Loading and Passing Applier

Load additional clips and pass the applier through the trocar after placing the suture.

Positioning Clip on Tissue

Slide clip down suture until it contacts tissue. Avoid excessive tension to prevent slippage.

Verifying Clip Closure

Close applier jaws by squeezing handle until clip is locked. Surgeon must verify closure and security.

Overview

1. Function Description
2. Important Technical Specifications
3. Usage Features
4. Maintenance Features

The LAPRA-TY® Suture Applier is a medical device designed for applying suture clips during surgical procedures. It is optimized for performance and is intended to enhance the efficiency and security of suture placement.

Function Description:

The primary function of the LAPRA-TY® Suture Applier is to securely place LAPRA-TY® Suture Clips onto specific types and sizes of suture material. This device facilitates the creation of secure ligatures in a controlled manner, particularly in situations where traditional knot tying might be challenging or time-consuming. The applier is designed to grasp and deploy a single suture clip at a time, ensuring precise placement and secure closure. It is used in conjunction with LAPRA-TY® Suture Clips, which are pre-loaded into cartridges. The applier's jaws are inserted into a cartridge slot to pick up a clip, which is then positioned on the suture and closed.

Important Technical Specifications:

The LAPRA-TY® Suture Applier is specifically designed to be used only with LAPRA-TY® Suture Clips and only with Coated VICRYL® (polyglactin 910) Suture in sizes 2-0, 3-0, or 4-0. The device's design ensures compatibility and optimal performance with these specific materials. Using suture materials other than the indicated types and sizes (e.g., MONOCRYL®, PROLENE®, PDS®) or clips not designed for the system may lead to insufficient clip security and compromise the integrity of the ligature. The applier features a mechanism that visibly locks the clip upon closure, allowing the surgeon to verify security. The clips are designed to be placed approximately 5mm from the cut end of the suture, and care must be taken to avoid placing the suture near the latch to ensure proper latch security.

Usage Features:

1. Clip Loading: To load a clip, the applier's jaws are inserted into an individual cartridge slot, ensuring the tips are perpendicular to the cartridge surface. This precise alignment is crucial for correctly picking up a clip.
2. Suture Placement: After the suture has been placed using standard continuous or interrupted techniques, an additional clip is loaded onto the applier. The loaded applier is then passed through the trocar to access the surgical site.
3. Clip Positioning: The clip is positioned by sliding it down the suture until it makes contact with the tissue. It is important to note that excessive tension during this step may cause clip slippage, which could compromise the security of the ligature.
4. Clip Closure and Verification: The applier jaws are closed by squeezing the handle until the clip is visibly locked. Surgeons must verify the closure and security of the clip to ensure effective ligation.
5. Material Specificity: The device's performance is highly dependent on the correct use of materials. It is explicitly stated that LAPRA-TY® Suture Clips are not intended for use with suture materials other than 2-0, 3-0, or 4-0 Coated VICRYL® (polyglactin 910) Suture. This specificity is a critical usage feature to prevent complications related to insufficient clip security.

Maintenance Features:

While specific maintenance features like cleaning protocols or sterilization instructions are not explicitly detailed in the provided text, the emphasis on "Optimized Device Performance Guide" suggests that proper handling and adherence to usage guidelines are paramount for maintaining the device's functionality. The instructions imply that the device is designed for reliable performance when used according to the specified parameters. The need to reference the "Instructions for Use" for all product details, including warnings and precautions, indicates that comprehensive maintenance and care guidelines would be found in that document. This typically includes information on cleaning, sterilization, inspection for damage, and proper storage to ensure the device remains in optimal working condition and safe for patient use. The robust design, as suggested by the visual representation, implies durability under normal surgical use, but specific maintenance routines would be crucial for its longevity and consistent performance.

Johnson & Johnson ETHICON LAPRA-TY Suture Applier Specifications