DORMIA® FRONT STONE EXTRACTOR BRIEF STATEMENT
Intended Purpose
Stone retrieval devices serve for the endoscopic removal of stones and their fragments from the urogenital and gastroenterological tract during the course of retrograde interventions.
Indications
For stone removal during the course of rigid and flexible ureterorenoscopy, cystoscopy, endoscopic retrograde cholangioscopy (ERC), endoscopic retro-grade cholangiopancreatography (ERCP).
Contraindications
The contraindications of the above endoscopic interventions apply. The stone retrieval devices may not be used for Percutaneous Nephrolithotomy (PNCL). Stone retrieval devices may not be used for intravascular applications or other application areas, as sufficient clinical experience is lacking for this.
Warnings
If used improperly, stone retrieval devices can cause the perforation of tissue, in particular if the stones are lodged on the vessel wall. The stone bed is then frequently very fragile. The use of contrast media can lead to adhesions that can limit the functionality of the stone retrieval device. Some stones may be too large to be removed with the stone retrieval device through the endoscope because the stone could get stuck in the working channel of the endoscope during removal. Therefore, always the complete system of endoscope and retrieval device shall be removed and the retrieval device shall be emptied outside the human body. Stone retrieval devices may not be used for mechanical stone crushing (lithotripsy).
Precautions
This type of device must be used only by trained and experienced professionals. If excessive force is used, there is a potential for vessel wall tear. Do not use the stone retrieval device if the stone is too large.
Potential Complications
The following complications are possible when using stone retrieval devices for stone removal: Entrapment of large stones, inability to disengage the dislodger from irretrievable stones requiring the application of other interventions, tissue perforation, breakage of the stone retrieval device, infection, and non-retrievable stones.
The risks and benefits of using Dormia® Front Stone Extractor should be considered in patients.
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.
DORMIA® NO-TIP BRIEF STATEMENT
Indications
The Dormia® No-Tip nitinol stone extractor is an interventional endourological device used to remove stones and stone debris following lithotripsy, located in urinary tract, through percutaneous access or through retrograde natural access.
Contraindications
Contraindications to the medical device
- The device is not intended for use other than for endourological procedure.
- Do not use, when, in the judgement of the physician, such a procedure would be contrary to the best interest of the patient.
- The device contains nitinol materials. Do not use in case of patient’s known allergy to device materials.
Contraindications to the endourological procedure
- Untreated urinary tract infection.
- Uncontrolled haemostasis disorder.
- Malignant kidney or urinary tract tumor
- PerCutaneous NephroLithotomy (PCNL)
procedure is not indicated in: - Pregnancy unless exceptional situation
- Bleeding disorders
Warnings and Precautions
This device must only be used by trained and experienced physicians. Do not use REF. EXN434 with a flexible endoscope.
Potential Complications
Adverse events involving patients have been reported, which may be related to the procedures used or problems occurring with the device (such as detachment of a part of the device, breakage, or inability to withdraw the basket), especially if the operating procedure and the warnings above are not observed, although their occurrence greatly depends on patients’ medical conditions. Adverse events include but are not limited to: Tissue trauma (mucosal abrasion, perforation), infection (e.g. urinary tract infection, pyelonephritis, severe infection…), pain, bleeding, haematuria, foreign object in body, device embedded in tissue, prolonged procedure and stone impaction.
Advice to Patients
Patients should be educated on the interventional procedure and be advised to inform the physician immediately if any abnormality or adverse event occurs (e.g., hematuria, infection, pain).
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.
DORMIA® N.STONE BRIEF STATEMENT
Indications
The Dormia® N.Stone® nitinol stone extractor is an interventional endourological device used to remove stones and stone debris following lithotripsy, located in urinary tract, through percutaneous access or through retrograde natural access.
Contraindications
Contraindications to the medical device
- The device is not intended for use other than for endourological procedure.
- Do not use, when, in the judgement of the physician, such a procedure would be contrary to the best interest of the patient.
- The device contains nitinol materials. Do not use in case of patient’s known allergy to device materials.
Contraindications to the endourological procedure
- Untreated urinary tract infection.
- Uncontrolled haemostasis disorder.
- Malignant kidney or urinary tract tumor
- PerCutaneous NephroLithotomy (PCNL)
procedure is not indicated in: - Pregnancy unless exceptional situation
- Bleeding disorders
Warnings and Precautions
This device must only be used by trained and experienced physicians. Do not use with a flexible endoscope.
Potential Complications
Adverse events involving patients have been reported, which may be related to the procedures used or problems occurring with the device (such as detachment of a part of the device, breakage, or inability to withdraw the basket), especially if the operating procedure and the warnings above are not observed, although their occurrence greatly depends on patients’ medical conditions.
Adverse events include but are not limited to: Tissue trauma (mucosal abrasion, perforation), infection (e.g. urinary tract infection, pyelonephritis, severe infection…), pain, bleeding, haematuria, foreign object in body, device embedded in tissue, prolonged procedure and stone impaction.
Advice to Patients
Patients should be educated on the interventional procedure and advised to inform the physician immediately if any side effect occurs (e.g., blood in the urine, signs of infection).
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.
