IceCure™ Medical Ltd.
DMS-7064 rev. C
ProSense™
Confidential
User Manual
28
European User Manual
Laparoscopic procedure
•
Mild/moderate
adverse events: vascular and visceral injury, general anesthesia related
AE, pneumoperitoneum (that can cause hemodynamic alterations), post procedural
abdominal adhesions, abdominal wall hematoma, wound infection and fascial injury.
•
Severe
adverse events: vascular and visceral injury, general anesthesia related AE, port
site metastasis, pneumoperitoneum (that can cause hemodynamic alterations), post
procedural abdominal adhesions, cryoprobe and trocar insertion include injuries to major
retroperitoneal vessels and to bowel, abdominal wall hematoma, fascial dehiscence and
herniation, umbilical hernia, and umbilical wound infection.
Breast - Fibroadenoma and breast cancer:
•
Mild/ moderate
adverse events: bleeding from breast puncture site, local breast
hematoma, local breast infection and thermal injury to the breast skin, breast skin
bruising, breast swelling, ecchymosis, edema, fat necrosis.
•
Severe
adverse events: thermal injury.
Urology - Renal and Prostate:
•
Mild/moderate
adverse events: adjacent organ injury, allergic reaction, bleeding, DVT,
cystitis , Hematuria, hypotension, Idiosyncratic reaction, ileus, infection, pleural effusion,
pneumothorax,
cryoprobe
site paresthesia, , mild renal failure, renal infract, voiding
dysfunction, urinary tract obstruction, hematomas, ejaculatory dysfunction, erectile
dysfunction, penile paresthesia, pelvic pain, perineal pain.
•
Severe
adverse events: abscess, adjacent organ injury, renal artery/renal vein injury,
anaphylactic reaction, coronary ischemia, myocardial infraction, bleeding, death, DVT,
hypotension, pulmonary embolism, severe renal failure, stroke, Idiosyncratic reaction,
ileus, infection lumbar radiculopathy, pelvic vein thrombosis, pleural effusion,
pneumothorax, renal hemorrhage , severe urinary tract obstruction, renal vein
thrombosis, rectourethral fistula, scrotal edema, ureteral stricture, renal infract, sepsis,
urinary tract leak, urethral sloughing, urethral stricture, urinary fistula, urinary
frequency/urgency, urinary incontinence, urinary retention, bladder neck contracture,
stroke, need for transfusion due to hemorrhage, tumor seeding, gastro intestinal tract
injury.
Thoracic surgery - Lung and cardiac arrhythmia:
•
Mild/moderate
adverse events: frostbite, respiratory failure, pneumothorax,
Hemothorax, pleural effusion, pneumonia, empyema, hemoptysis, lung collapse,
thrombosis, phrenic nerve palsy, Pain, fever, cough, back pain, skin injury, pulmonary
