COOK Medical Biodesign Mode D'emploi page 3

BIODESIGN® SURGISIS® ANAL FISTULA PLUG
INTENDED USE
The Cook® Biodesign® Surgisis® Anal Fistula Plug is for implantation to
reinforce soft tissue where a rolled configuration is required, for repair of
anorectal fistulas. The plug is supplied sterile and is intended for one-time use.
Rx ONLY
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CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the
order of a physician.
Surgisis® Anal Fistula Plug
This product is intended for use by trained medical professionals.
CONTRAINDICATIONS
• This plug is derived from a porcine source and should not be used in
patients sensitive to porcine materials.
• Not for vascular use.
PRECAUTIONS
• Do not resterilize. Discard all open and unused portions.
• Plug is sterile if the package is dry, unopened and undamaged. Do not use
if the package seal is broken.
• Discard plug if mishandling has caused possible damage or contamination,
or if the plug is past its expiration date.
• Do not implant the plug in a grossly infected or abscessed fistula tract. A
seton should be used until there is no evidence of acute inflammation,
purulence, or excessive drainage. Allow the tract to mature and
stabilize for six to eight weeks before placing the plug.
• Ensure that the plug is rehydrated prior to placement, cutting, or suturing.
GENERAL
• Users should be familiar with surgical technique for anorectal fistula repair.
• Users should exercise good surgical practice for the management of clean-
contaminated, contaminated or infected fields.
• The potential for infection of the graft material following implantation
may be reduced by the use of prophylactic antibiotics, and cleaning of the
fistula tract. (See Use of Antimicrobials)
• The plug should be handled aseptically, minimizing contact with latex
gloves.
• The plug should be introduced through the internal (primary) fistula
opening.
• The plug should be drawn into the fistula tract only until the internal
(primary) opening is satisfactorily closed / occluded.
• The external (secondary) opening of the fistula tract should remain open.
• IMPORTANT: Users should counsel patients on abstaining from strenuous
activity for a period of two weeks after plug placement. See Post-Operative
Care section.
• Expect some drainage for two to four weeks. Drainage can continue
for up to 12 weeks after the procedure as the plug is incorporated and
the fistula tract is closed.
POTENTIAL COMPLICATIONS
Complications that can occur with the plug include, but are not limited to:
• Inflammation
• Induration
• Migration
• Extrusion
• Seroma formation
• Infection
• Abscess
• Fistula recurrence
• Delayed or failed incorporation of the plug
If any of the following conditions occur and cannot be resolved, plug removal
should be considered:
• Infection
• Abscess
• Acute or chronic inflammation (Initial application of surgical graft materials
may be associated with transient, mild, localized inflammation)
• Allergic reaction
STORAGE
This plug should be stored in a clean, dry location at room temperature.
STERILIZATION
This plug has been sterilized with ethylene oxide.
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ENGLISH