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BEFORE USING THIS PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY.
IMPORTANT!
1.
This booklet is designed to assist using this product. It is not a reference to surgical techniques.
2.
This device was designed, tested and manufactured for single use patient use only.
3.
Reuse of this device may lead to its failure and subsequent patient injury.
4.
Reprocessing and/or re-sterilization of this device may create risk of contamination and patient infection.
5.
Do not reuse, reprocess or re-sterilize this device
DESCRIPTION
The GENICON Single-Use Specimen Retrieval Bag is comprised of a flexible plastic bag with a large, easily accessible opening, a push-pull rod with thumb ring
handle, finger rings, string and closure suture, and an introducer shaft. In the fully deployed condition, the bag opening is maintained in a fully-open position by a
metallic rim. A string with a closure suture facilitates closure of the specimen bag after the specimen had been collected. This device is packaged and sterilized for
single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.
INDICATIONS FOR USE
The GENICON Specimen Retrieval is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
CONTRAINDICATIONS
The use of GENICON laparoscopic and endoscopic products is contraindicated whenever endoscopic surgical techniques are contraindicated for any reason.
Contraindications relevant to individual GENICON products are noted in the specific sections.
WARNINGS AND PRECAUTIONS
1.
Endoscopic surgery should be performed only by physicians who are thoroughly trained in endoscopic techniques and failure modes, precautions, and
corrective actions in the event of failure.
GENICON single-use products are intended for single patient use only – DO NOT RESTERILIZE.
2.
3.
Do not use any pre-sterilized products if the packaging sterile barrier is damaged
4.
Consult medical literature or country specific regulations for specific techniques, complications, and hazards prior to procedure.
5.
Care must be taken when using laparoscopic instrumentation to avoid damage to major vessels and other anatomic structures.
6.
Establish and maintain adequate pneumoperitoneum to reduce the risk of injury to internal structures.
7.
Properly position the patient and note anatomical landmarks to introduced devices without unintended damage.
8.
Do not use morcellators with this device
9.
Care should be taken to avoid contact of the bag with sharp instruments, cutting devices, and electrosurgical and laser instrument.
10. This device is not intended for use with any tissue that will not fit within the confines of the specimen bag and allow complete closure of the bag.
11. Do not attempt to remove the specimen through the trocar or cannula as this may lead to bag rupture and spillage of contents.
12. The specimen bag includes a radiopaque thread that is clearly visible on CT Scans and may be visible in standard, plain radiography.
13. Excessive forces should be avoided during bag extraction.
14. If the bag and its contents are too large to be extracted, carefully enlarge the access site to facilitate easy bag removal.
15. Verify that the devices are compatible with other products that will be used in surgery prior to the procedure.
16. Transport and store all products safely at ambient temperatures of 5°C to 30°C and relative humidity of 35% to 65 % (non-condensing). Handle with care.
17. Dispose of all used or damaged products using standard hospital practices for biohazard control.
POTENTIAL COMPLICATIONS FOR ALL GENICON
Potential complications associated with the use of laparoscopic devices include but are not limited to organ or vessel damage/perforation, hemorrhage, hematoma,
trocar site hernia, and septicemia/infection.
INSTRUCTIONS FOR USE
1.
Inspect all components carefully for damage during shipment, handling or after maintenance. Refer to picture -1-
A.
Specimen Bag
B.
Introducer Shaft
C.
Finger Rings/Grip
D.
Thumb Ring/Push-Pull Rod
E.
Tether with Radiopaque Marker
F.
Closure Suture
2.
Inspect sterile packaging, and verify that sterile barriers are intact. Do not use if package is compromised.
3.
Verify that the sizes of all surgical components selected are compatible.
4.
Open package using sterile technique and place instrument on sterile field.
5.
Pull back on the thumb ring until the bag is inside the Introducer shaft. Refer to picture -2-
6.
Insert the instrument through the desired corresponding sized port. Refer to picture -3-
7.
Holding the finger rings, depress the thumb ring. This will advance and deploy the specimen bag/opening support rim into the body cavity. The product logo
on the distal end of the introducer tube indicates the position of the bag opening. Refer to picture -4-
8.
Place specimen into the specimen bag. Refer to picture -5-
9.
Once the specimen is completely within the bag, use one of the following steps to remove the specimen.
TO REMOVE THE INSTRUMENT, SPECIMEN BAG, AND CANNULA TOGETHER:
A-1. Secure the specimen by pulling back on the thumb ring to retract and close the bag.
A-2. Grasp the instrument and cannula and carefully remove from the access site together.
NOTE: This method will allow the bag to be redeployed on the same patient. To redeploy the bag, do not pull the closure suture and then repeat steps 5
through 9 above once specimen has been removed from bag.
NOTE: If the bag and its contents are too large to be extracted, carefully enlarge the access site to facilitate easy bag removal.
TO REMOVE THE SPECIMEN BAG AND CANNULA TOGETHER:
B-1. To separate the bag from the instrument, release the tether from the thumb ring. Refer to picture -6-
B-2. Once the tether has been released, withdraw the thumb ring/push-pull rod from the introducer shaft, leaving the bag within the body cavity and the tether
accessible through the introducer shaft. Refer to picture -7-
B-3. Pull the closure suture until the bag is completely cinched closed. Refer to picture -8-
B-4. Remove the introducer shaft from the cannula, thus leaving the tether exposed though the cannula. Pull up on the tether until the leading edge of the bag is
inside the tip of the cannula. Carefully remove the cannula with the bag and specimen from the access site.
NOTE: If the bag and its contents are too large to be extracted, carefully enlarge the access site to facilitate easy bag removal.
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