IceCure™ Medical Ltd.
DMS-7063 rev. C
ProSense™
Confidential
User Manual
26
US User Manual
urinary incontinence, urinary retention, bladder neck contracture, stroke, need for
transfusion due to hemorrhage, tumor seeding, gastro intestinal tract injury.
Oncology and Cryoanalgesia
Mild/moderate
adverse events: muscular injury, pain, swelling, osteonecrosis,
osteomyelitis, chondrolysis, nerve palsy, motor dysfunction, peri-ablational neuropathies.
Severe
adverse events: compartment syndrome osteonecrosis, osteomyelitis,
chondrolysis, nerve palsy, motor dysfunction, peri-ablational neuropathies, bowel damage,
urinary tract damage, pericardial effusion in (in chest wall ablations), avascular necrosis of
femur head, ureteral stricture.
Dermatology
Mild/ moderate
adverse events: skin burn/frostbite, wound complication and wound
infection.
Gynecology
Mild/ moderate
adverse events
:
spotting, urinary tract infection, treatment site infection,
uterine bleeding, genitourinary perforation, pelvic pain.
General surgery
Mild/moderate
adverse events
:
infection, bleeding, pain, fever, thermal injury, injury to
adjacent organs, pneumonia, fall, internal adhesions, changes in the laboratory
parameters-elevation in aspartate aminotransferase and/ or alanine aminotransferase
level (this reflects hepatocellular damage), minimal self-limited serum bilirubin level
elevation, hemorrhage, hematoma, myoglobinemia, pleural effusion, hemothorax,
pneumothorax, thrombosis, diarrhea, nausea, deep vein thrombosis (DVT), transient
ischemic attack, hypertension, hypothermia, treatment site reaction, local neuropathy,
frostbite, skin burn, vagal reaction, vomiting, needle seeding, user accidental injury.
Severe
adverse events
:
infection, thermal injury, procedure done on the wrong patient/
part of the body, retention of foreign object after surgery, pulmonary emboli, congestive
heart failure, stroke, fall, severe changes in the laboratory parameters-elevation in
aspartate aminotransferase and/ or alanine aminotransferase (this reflects hepatocellular
damage), life threatening serum bilirubin level elevation, perirenal fluid collection,
hemorrhage, cryoshock (hypotension), respiratory compromise, multi organ failure,
disseminated intravascular coagulation (DIC), abscess, pleural effusion, hemothorax,
pneumothorax, thrombosis of the portal vein branches, allergic/anaphylactoid reaction,
angina/coronary ischemia, myocardial infarction, arrhythmia, atelectasis, adjacent organ
injury.
Anesthesia
Mild/moderate
adverse events
:
hypoxia, hypotension -low blood pressure, cough, residual
neuromuscular block in recovery, intubation complications, slow to regain consciousness,
anesthetic turn off too early.
Severe
adverse events
:
hypoxia, hypotension -low blood pressure, residual neuromuscular
block in recovery.
