CapSure™ provides surgeons the confidence they desire through strong and reliable fixation.
- Overview
- Specifications
- eIFUs and Resources
- FAQ
- Product Notifications
Permanent Fixation Redefined
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FEATURE AND BENEFIT CARDS NOT AVAILABLE
FEATURE AND BENEFIT CARDS NOT AVAILABLE
GTIN - Case
10801741094986
5
GTIN - each
00801741094989
1
Quantity
5/cs
Dimensions
CapSure™ Permanent Fixation System - 15 Fasteners
GTIN
| GTIN - Case | 10801741094986 | 5 |
| GTIN - each | 00801741094989 | 1 |
Packaging
| Quantity | 5/cs |
Product Basic Specification
| Dimensions | CapSure™ Permanent Fixation System - 15 Fasteners |
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Things to Consider
If you are a patient or end user, you can contact us yourself, or you may have your caregiver or your physician do that for you. To help us process your
information quickly and effectively, please contact our customer complaints
team.
To better facilitate our investigation, please include the following information in your reporting:
- Product Name and/or Catalog Number
- Lot Number or Serial Number
- Any injuries and/or Harm?
- What is the issue you experienced?
- Is the actual sample or sample representative available? (If possible, please send affected sample)
- Contact name and phone number
1. Bench top data. Results many not correlate to performance in humans.
2 Preclinical data. Results may not correlate to performance in humans
Indications
The CapSure™ Permanent Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.
Contraindications
Carefully inspect the area in the vicinity of the tissue being fastened to avoid inadvertent penetration of underlying structures such as bone, nerves, vessels, and viscera. Use of the CapSure™ Permanent Fixation System in the close vicinity of such underlying structures is contraindicated. For reference, the length of the fastener below the fastener head is 3.2 mm, the fastener head is another 1 mm (total 4.2 mm).
Precautions
Adequate counter pressure should be applied on the target area. Avoid placing hand or finger directly over the area where fastener is being deployed to prevent injury. Use caution when applying the CapSure™ fastener over or in proximity to underlying bone, vessels, nerves, or viscera. The intended fixation site should be assessed to ensure that while the tissue is compressed the total distance from the surface of the tissue to any underlying structures is greater than the length of the CapSure™ fastener. Adverse Reactions
Adverse reactions and potential complications associated with fixation devices such as the CapSure™ Permanent Fixation System may include, but are not limited to the following: hemorrhage, pain, edema and erythema at wound site; septicemia/infection; hernia recurrence/wound dehiscence, erosion and allergic response in patients with known sensitivities to PEEK and metals contained in 316L stainless steel, including chromium, nickel, copper, and iron.
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