Capio™ SLIM Suture Capturing Device

The Capio SLIM Device is intended for use in general suturing applications during urogynecologic surgery to assist in the placement of suture material in tissues at the operative site. It is also intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical grafts during urogynecologic procedures. The Capio SLIM Device is to be used with sensory and/or direct visual control.

The use of the Capio SLIM Device is contraindicated as follows:

• For placing sutures into or through bone.

• Punctures or lacerations of vessels, nerves, bladder, urethra or bowel may occur during placement and may require surgical repair.
• Once the suturing action has begun, do not turn, rotate or torque the Capio SLIM Device. To do so, may result in injury.

• Use only size 0 Capio Sutures with the Capio SLIM Device.
• The physician is advised to consult the medical literature regarding techniques, complications and hazards associated with the intended procedures.
• The Capio SLIM Device is not intended to be used to manipulate tissue, organ or bone.
• Do not bend or alter the device as this may result in mechanical damage to the device.

Potential complications associated with the Capio SLIM Device include, but are not limited to:

• allergic reaction
• bleeding
• dyspareunia
• hematoma
• infection
• inflammation
• injury to internal organs/tissue including perforation and occlusion
• injury to vessels and nerves
• pain
• unretrieved device fragment