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Emprint™ ablation system
Indications for Use
The Emprint™ ablation system is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, such as lung, kidney, and liver, including partial or complete ablation of non-resectable liver tumors.
Contraindications
Microwave ablation procedures are not recommended for pregnant patients or patients with cardiac pacemakers or implanted electronic devices. The Emprint™ ablation system is not intended for use in cardiac procedures.
Residual Risk Summary
While every attempt has been made to reduce patient and user risks, all surgeries using this device carry some residual risk, even when used by trained physicians. Residual risks include: ascites, abscess, intra-abdominal abscesses, additional needle stick/puncture, atrial fibrillation, biliary stenosis, biloma, cancer (cancer seeding), cardiomyopathy, cholangitis, colonic perforation, death, delay of treatment, dyspnea, emphysema, exacerbation of lung disease, foreign body in patient, foreign body reaction, gastrointestinal fistula, haemobilia, hematoma, hemoptysis, hemorrhage, hemothorax, hepatic infarction, hepatic insufficiency, infection, inflammation, ischemia, necrosis, pain, peritonitis, pleural effusion, pneumothorax, post ablation syndrome, pulmonary/upper respiratory fistula, renal failure, renal fistula, seroma, tachycardia, urinary retention, urinary tract stenosis, wound dehiscence.
Important: Always refer to the Instructions For Use (IFU) packaged with the product for complete instructions, indications, contraindications, warnings and precautions. This material is only intended for distribution in Europe. Indications, claims, and intended use may be different in other regions.
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