PRODUCT
Intended purpose
Indication
Disposable Powered Endoscopic Stapler, combined with BEIEN'S Disposable Powered Endoscopic Reload Unit, are intended for transection, resection and anastomoses. The instruments have application in multiple open or minimally invasive thoracic, general surgical procedures. The instrument can be used for transection, resection and anastomoses of intestines, stomach, lungs and esophagus.
Manufacturer Specification
Product Name: Disposable Powered Endoscopic Stapler - BNJL Series
Manufacturer: Wuxi Beien Surgery Device Co., Ltd.
EU Authorized Representative: Prolinx GmbH
Brand:
Product Information
|
Code |
Description |
Shaft Length |
|
BNJL-SA |
Powered Endoscopic Stapler - Short |
63mm |
|
BNJL-CA |
Powered Endoscopic Stapler - Conventional |
155mm |
|
BNJL-EA |
Powered Endoscopic Stapler - Extra |
255mm |
|
BNJL-SC |
Powered Endoscopic Stapler - Short |
63mm |
|
BNJL-CC |
Powered Endoscopic Stapler - Conventional |
155mm |
|
BNJL-EC |
Powered Endoscopic Stapler - Extra |
255mm |
Contraindications
2.Tissue thickness should be carefully evaluated before firing any stapler. Refer to the Instructions for Use provided with the selected Disposable Powered Endoscopic Reload Unit for the specific contraindications regarding compressed tissue thickness for the selected reload.
3.Do not use Disposable Powered Endoscopic Stapler where adequacy of hemostasis cannot be verified visually after applications.
4.Do not use the instrument on vascular anastomosis, ischemic or necrotic tissue, inflammation, mucosal edema and suspected residual cancerous tissue at tumor site and incisal end.
5.Disposable Powered Endoscopic Stapler should not be used on friable or delicate tissue where the closure of the device might be destructive.
6.Disposable Powered Endoscopic Stapler is provided STERILE and is intended for use in a SINGLE procedure only. DISCARD AFTER USE. DO NOT RESTERILIZE.
7.Disposable Powered Endoscopic Reload Unit are is STERILE and are intended for use in a SINGLE procedure only. DISCARD AFTER USE. DO NOT RESTERILIZE.
Undesirable Side Effects/ Residual Risks
Precautions and Warnings
2. Do not use the stapler if the packaging or device components appear damaged.
3. Endoscopic procedures should be performed only by physicians having adequate training and familiarity with endoscopic techniques. Prior to performing any endoscopic procedures, consult the medical literature relative to techniques, complications, and hazards.
4. The stapler and associated components are to be used by medical professionals qualified in the transportation, sterilization, and use of surgical devices. Disposable Powered Endoscopic Reload Unit is intended for use in a sterile operating room environment in surgical procedures where surgical stapling is indicated.
5.The Disposable Powered Endoscopic Stapler with a 2.5mm staple is not suitable for any tissue compressed to a thickness of less than 1.5mm, as well as any tissue that cannot be compressed to a thickness of 2.0mm or above on the aorta; it is applicable to 12mm inner diameter puncture tubes.
6.The Disposable Powered Endoscopic Stapler with a 3.5mm staple is not suitable for any tissue that has been compressed to a thickness of less than 2.0mm, as well as any tissue that cannot be compressed to a thickness of 2.5mm or above on the aorta; it is applicable to a 12mm inner diameter puncture tube.
7.The Disposable Powered Endoscopic Stapler with a 4.5mm staple is not suitable for any tissue that has been compressed to a thickness of 2.5mm or less, as well as any tissue that cannot be compressed to a thickness of 3.0mm or tissue on the aorta; it is applicable to a 15mm inner diameter puncture tube.
8. The Disposable Powered Endoscopic Stapler with a 2.5mm staple is not suitable for any tissue that has been compressed to a thickness of 1.0mm or less, as well as any tissue that cannot be compressed to a thickness of 1.3mm or tissue on the aorta.
9. The Disposable Powered Endoscopic Stapler with a 3.5mm staple is not suitable for any tissue that has been compressed to a thickness of 1.5mm or less, as well as any tissue that cannot be compressed to a thickness of 2.0mm or tissue on the aorta.
10. The Disposable Powered Endoscopic Stapler with a 4.0mm staple is not suitable for any tissue that has been compressed to a thickness of 1.8mm or less, as well as any tissue that cannot be compressed to a thickness of 2.3mm or tissue on the aorta.
11. The Disposable Powered Endoscopic Stapler with a 4.8mm staple is not suitable for any tissue that has been compressed to a thickness of 2.0mm or less, as well as any tissue that cannot be compressed to a thickness of 2.5mm or tissue on the aorta.
12.In general, it is not advisable to apply this to: vascular anastomoses, ischemic or necrotic tissue, inflammation, mucous membrane edema, and tumor sites; as well as areas where there may be residual cancerous tissue at the cut ends.
13.If after using the stapler, it is impossible to visually confirm that adequate bleeding has stopped, do not use this product.
14.This product has undergone EO/ irradiation sterilization treatment and is intended for single-use only. After use, it must be discarded and not re-sanitized for reuse.
15.Where surgical suturing is contraindicated, this device should not be used.
16.Where an initial mechanical anastomosis fails, it is generally advisable not to attempt a second mechanical anastomosis.
17. Before each use, the outer surface of the device inserted into the patient's body should be checked to ensure that there are no unexpected rough surfaces, sharp edges, or protrusions that may cause injury.
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