Digitex^® Suture Delivery System

For ordering information, please call 800.258.3476.

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.

OUS: The Digitex Suture Delivery System (SDS) is a single-use, non-active, sterile, disposable device intended to place suture with or without direct visualization. It is indicated in a variety of obstetric-gynecologic, transvaginal surgical procedures including correction of pelvic organ prolapse. The Digitex Suture Cartridge intended for use with the Digitex Suture Delivery Device holds sterile polypropylene suture indicated for soft tissue approximation. The device assists in suturing by passing a needle through the tissue to capture the suture, and suture ligation and knot-tying by holding the suture.

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.

Procedure Warnings
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.

Adjustments 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.

Product Precautions
The delivery device is not intended for use as a retractor, dissector, probe or any purpose other than delivering suture.

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

The 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), injury to abdominal wall, 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
12/15/2021
PM-04598