Digitex® Suture Delivery System

Digitex Suture Delivery System allows for fixation of native tissue or any graft material—either synthetic or biologic. Digitex is indicated for both general surgery and a variety of obstetric-gynecologic procedures, including pelvic floor repair.

For ordering information, please call 800.258.3476.

Brief Statement

Indications
The Digitex Delivery Device is a single use device intended for use as an aid in suturing during transvaginal pelvic organ prolapse procedures with surgical mesh. The Digitex Suture Cartridge holds sterile suture indicated for soft tissue approximation.

Contraindications
It is the responsibility of the physician to advise the prospective patients or their representatives, prior to surgery, of the contraindications associated with the use of this product. The Digitex Delivery Device is contraindicated for use in:

  • Patients who are not candidates for surgical procedures
  • Applications requiring placement of suture into or through bone
  • Patients with known sensitivities or allergies to its components
  • Cardiovascular procedures

Warnings
The Digitex Suture Delivery System should only be used by physicians familiar with the
surgical procedures and techniques involving suture placement, as wound healing may vary with the site of application, suture material used and patient characteristics.

Obtain patient consent prior to surgery and ensure that the patient has an understanding of the postoperative risks and potential complications of suture placement.

The use of absorbable suture may influence durability and success based on individual patient characteristics.

Do not use product that has damaged or opened packaging, or has expired, as sterility may be compromised.

For absorbable suture, store at room temperature as exposure to elevated temperatures could affect suture performance.

The malleable shaft of the Digitex Delivery Device has been designed to function at various angles < 15°. The Physician should be aware that changes in the angle of the shaft result in changes in needle delivery angle. Adjustments to the malleable shaft of < 15° are within device design specifications, changes greater than 15° may result in premature shaft fatigue, engagement failure or disengagement failure. Once the Digitex Delivery Device needle has been engaged into tissue, the device should not be rotated, angled or otherwise moved; disruption of the engaged needle and suture cap could result in patient injury. A digital rectal exam should be performed to detect possible rectal perforation. The Digitex Delivery Device is provided sterile (ethylene oxide sterilization) and is for single-use only. The delivery device is not intended for use as a retractor, dissector, probe or any purpose other than delivering suture.

Precautions
As anatomy of individual patients may vary greatly, it is important that the intended locations for suture placement are planned for each procedure and each individual patient.

The Digitex Delivery Device is designed to be used only with the Digitex Suture Cartridge, which incorporates a specially designed suture cap.

Use caution to prevent intraoperative injury.

Do not engage the delivery device without the cartridge and suture cap securely loaded, as the operating mechanism for grasping the suture could be damaged.

Inadequate lever travel could result in a failure to engage the needle into the cap.

The stainless steel crimp (with absorbable suture only), suture cap and crescent needle are not intended to be implanted.

Potential Complications
The adverse events associated with the use of the Digitex SDS (device and suture cartridges) to place sutures may include but are not limited to: Bleeding, calculus formation, dehiscence, hematoma, inadequate closure, inadequate fixation, infection, inflammation (acute or chronic), local irritation, pain (acute or chronic), perforation, injury, entrapment, or occlusion of soft tissue (e.g., ligaments, muscles, nerves, vessels), structures or organs (e.g., bone, bowel, rectum, bladder, urethra, ureters, vagina), peritonitis and suture erosion.

The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company Website at www.coloplast.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Minneapolis, MN
05/15/2018
PM-04598

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