stryker Reprocessed Suture Passer Instruction Manual
- July 29, 2024
- stryker
Table of Contents
- stryker Reprocessed Suture Passer
- Product Information
- Product Usage Instructions
- FAQ
- Reprocessed Device for Single Use
- Suture Passer Description
- Indications for Use
- Precautions
- Trocar Wound Closure Surgical Technique
- Warranty
- CONTACT
- References
- Read User Manual Online (PDF format)
- Download This Manual (PDF format)
stryker Reprocessed Suture Passer
Product Information
Specifications
- Product Name: Reprocessed Suture Passer
- Device Type: Single-use reprocessed device
- Sterilization Method: Ethylene Oxide Gas
- Components: Carter-Thomason suture passer, 5mm suture passer guide, 10-12mm suture passer guide
- Intended Use: Passing sutures through soft tissue during endoscopic/laparoscopic surgery
Product Usage Instructions
Suture Passer Description
- A Suture Passer is a set of three devices: Carter-Thomason suture passer, 5mm suture passer guide, and 10-12mm suture passer guide. The Carter-Thomason suture passer is used to pass sutures through soft tissue.
Indications for Use
- Reprocessed Suture Passers are intended for passing sutures through soft tissue during endoscopic/laparoscopic surgery.
Directions for Use
- Verify compatibility of all instruments and accessories before starting the procedure.
- Inspect packaging before opening to ensure sterility.
- Identify the operating positions of the suture passer: jaws open and jaws closed.
- Align the suture passer guide and pick up the suture.
- Pass the suture through soft tissue like muscle, and fascia, and guide as needed.
- Affix the detachable package label to the patient’s medical record.
FAQ
- Q: Can the Reprocessed Suture Passer be reused?
- A: No, the Reprocessed Suture Passer is a single-use device and should not be reused. Refer to the instructions for use for more details on proper handling and disposal.
Reprocessed Device for Single Use
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
STERILE
Explanation of Icons
- Sterilized by Ethylene Oxide Gas
- Date of Reprocessing
- Use by Date
- Product Code
- Do Not Reuse
- See Instructions For Use
Suture Passer Description
- A “Suture Passer” is actually a set of three devices: one Carter-Thomason suture passer, one 5mm suture passer guide, and one 10-12mm suture passer guide.
- The Carter-Thomason suture passer is a ring-handled suture-grasping device that is intended to pass suture through soft tissue.
Indications for Use
- Reprocessed Suture Passers are intended to pass sutures through soft tissue during endoscopic/laparoscopic surgery.
Warnings
- Package is provided sterile by the method of ethylene oxide gas and is for single-patient use only. Do not use if there is any evidence of damage to the package.
- Prior to use, read and follow the instructions of this insert as well as those of the instruments to be used during the procedure.
- Minimally invasive surgery should only be performed by qualified physicians trained in the techniques of the procedures. A thorough understanding of endoscopic/laparoscopic principles and techniques is required in order to minimize the risk of patient injury.
- The suture passer jaws can injure internal tissues. Do not use the suture passer in procedures where the position of the needle tip cannot be clearly ascertained.
- The suture passer jaws must be closed completely in order to form a needlepoint for insertion through tissue. Insertion through tissue without pressure on the plunger ring may cause the jaws to open, resulting in loss of the suture or inadvertent tissue capture.
- The suture passer tip can injure personnel if contacted by the pointed end of the jaws. The suture passer tip should be protected at all times when the suture passer is not in use.
Precautions
- Store instrument in a cool dry place.
- Use sterile techniques to remove the suture passer from its package and place on sterile surface. Replace the device if it is dropped outside of the sterile field.
- Ensure that the correct size suture passer guide is used for the trocar incision. Use of the incorrect size suture passer guide could compromise performance of the suture passer device.
- Do not hit the jaws of the suture passer on the suture passer guide when inserting the suture passer, as damage to the jaws may result.
Adverse Reactions
- None.
Directions for Use
The package label is detachable and may be affixed to the medical record of
the patient.
Suture Passer
The suture passer has two operating positions: jaws open and jaws closed.
- Before beginning the procedure, verify overall compatibility of all instruments and accessories.
- Inspect packaging before opening. The contents of the package are sterile if the package has not been compromised. Do not use the instrument if the sterility has been compromised. If the package is damaged or if it was opened and the instrument was not used, return the instrument and package to Stryker Sustainability Solutions.
- Do not attempt to resterilize.
- Inspect the instrument for overall condition and physical integrity. Do not use the instrument if any damage is noted. Return the instrument and packaging to Stryker Sustainability Solutions if it is not in acceptable condition for surgery.
- To open the needlepoint tip, pull back on the plunger ring.
- Lay suture in the jaw opening nearest the hinge.
- Close the jaws over the suture by releasing the plunger ring. This forms a needlepoint tip.
- Push the needlepoint tip (holding the suture) through the target tissue by pushing distally on the handle while maintaining a slight pressure on the plunger ring to keep the tip closed.
- When desired, open the jaw to release the suture.
- Close the jaw and remove the suture passer.
- Reinsert the suture passer near the first entry point.
- Repeat steps 1-3 to retrieve the suture and complete the stitch.
Trocar Wound Closure Surgical Technique
Step 1
- Insert the suture passer guide with the holes aligned cephalad to caudad.
- Use the Carter-Thomason suture passer to push suture material through the Suture passer guide, fascia, muscle, and peritoneum into the abdomen.
- Drop the suture, and remove the suture passer.
Step 2
- Push the suture passer through the opposite side of the Suture passer guide, and pick up the suture.
Step 3
- Pull the suture up through the peritoneum, muscle, fascia, and guide.
Step 4
- Remove the Suture passer guide and tie.
Warranty
Reprocessed Products
Stryker warrants all reprocessed products, subject to the exceptions provided
herein, to be free from defects in reprocessing and to substantially conform
to the product specifications contained in the documentation provided by
Stryker with the products for one use under the instructions for use of such
product.
STRYKER SHALL NOT BE LIABLE FOR ANY DAMAGES TO THE EXTENT CAUSED BY ANY DEFECT
IN MATERIAL, WORKMANSHIP OR DESIGN BY THE ORIGINAL MANUFACTURER OF THE PRODUCT
OR ANY ACT OR OMISSION OF THE ORIGINAL MANUFACTURER OF THE PRODUCT.
Products for which Stryker is the Original Manufacturer
Stryker warrants all products for which it is the original manufacturer,
subject to the exceptions provided herein, to be free from defects in design,
materials and workmanship and to substantially conform to the product
specifications contained in the documentation provided by Stryker with the
products for a period of one year from the date of purchase.
General Warranty Terms Applicable to All Products
TO THE FULLEST EXTENT PERMITTED BY LAW, THE EXPRESS WARRANTY SET FORTH HEREIN
IS THE ONLY WARRANTY APPLICABLE TO THE PRODUCTS AND IS EXPRESSLY IN LIEU OF
ANY OTHER WARRANTY BY STRYKER, EXPRESSED OR IMPLIED, INCLUDING, BUT NOT
LIMITED TO, ANY IMPLIED WARRANTY OR MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE. IN NO EVENT WILL STRYKER’S LIABILITY ARISING IN CONNECTION
WITH THE SALE OF THE PRODUCT (WHETHER UNDER THE THEORIES OF BREACH OF
CONTRACT, TORT, MISREPRESENTATION, FRAUD, WARRANTY, NEGLIGENCE, STRICT
LIABILITY OR ANY OTHER THEORY OF LAW) EXCEED THE PURCHASE PRICE, CURRENT
MARKET VALUE OR RESIDUAL VALUE OF THE PRODUCTS, WHICHEVER IS LESS. STRYKER
SHALL NOT BE LIABLE FOR INDIRECT, SPECIAL, INCIDENTAL, PUNITIVE OR
CONSEQUENTIAL DAMAGES RESULTING FROM ANY BREACH OF WARRANTY OR UNDER ANY OTHER
LEGAL THEORY.
This warranty shall apply only to the original end-user purchaser of products
directly from Stryker or a Stryker-authorized distributor. This warranty may
not be transferred or assigned without the express written consent of Stryker.
This warranty does not apply to: (1) products that have been misused,
neglected, modified, altered, adjusted, tampered with, improperly installed or
refurbished; (2) products that have been repaired by any person other than
Stryker personnel without the prior written consent of Stryker; (3) products
that have been subjected to unusual stress or have not been maintained in
accordance with the instructions in the user manual or as demonstrated by a
Stryker representative; (4) products on which any original serial numbers or
other identification marks have been removed or destroyed; or (5) products
that have been repaired with any unauthorized or non-Stryker components.
If a valid warranty claim is received within thirty (30) days of the
expiration of the applicable warranty period, Stryker will, in its sole
discretion: (1) replace the product at no charge with a product that is at
least functionally equivalent to the original product or (2) refund the
purchase price of the product. If a refund is provided by Stryker, the product
for which the refund is provided must be returned to Stryker and will become
Stryker’s property. In any event, Stryker’s liability for breach of warranty
shall be limited to the replacement value of the defective or non-conforming
part or component.
If Stryker determines in its reasonable discretion that the claimed defect or
non-conformance in the product is excluded from warranty coverage as described
hereunder, it will notify the customer of such determination and will provide
an estimate of the cost of repair of the product. In such an event, any repair
would be performed at Stryker’s standard rates.
Products and product components repaired or replaced under this warranty
continue to be warranted as described herein during the initial applicable
warranty period or, if the initial warranty period has expired by the time the
product is repaired or replaced, for thirty (30) days after delivery of the
repaired or replaced product. When a product or component is replaced, the
item provided in replacement will be the customer’s property and the replaced
item will be Stryker’s property. If a refund is provided by Stryker, the
product for which the refund is provided must be returned to Stryker and will
become Stryker’s property.
Reprocessed Suture Passer
The OEM information listed on the label is provided as device ID prior to
reprocessing and may contain the trademarks of unrelated third parties that do
not sponsor this device.
Sterilization: This product and its packaging have been sterilized with
ethylene oxide gas (EtO). Even though the product then is processed in
compliance with all applicable laws and regulations relating to EtO exposure,
Proposition 65, a State of California voter initiative, requires the following
notice:
Warning: This product and its packaging have been sterilized with
ethylene oxide. The packaging may expose you to ethylene oxide, a chemical
known to the State of California to cause cancer or birth defects or other
reproductive harm.
CONTACT
- Stryker Sustainability Solutions, Inc. © 2006, 2011
- 1810 W. Drake Drive
- Tempe, AZ 85283
- sustainability.stryker.com
- 888.888.3433
References
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>