y
A
A FDA Issues a Safety Communication on th
Dangers of Monopolar Laparoscopic Surg
• The FDA recently issued a Safety
Communication regarding capacitive
coupling and intraoperative insulation
failure and their risk of patient injury.
1
• Intraoperative stray energy burns are
a more prevalent issue than many
healthcare providers realize.
• Evidence shows that a patient is injured by
capacitive coupling or intraoperative insulation
failure every 90 minutes in the USA.
2-4
p
P
F A
Stray energy burns are completely
INSULATION FAIL
CAPACITIVE COU
he
gery.
1
URE*
UPLING*
preventable through the use of
appropriate technology.
T
T
• Active Electrode Monitoring (AEM
®
)
Technology is the only technology guaranteed
to eliminate both capacitive coupling and
intraoperative insulation failure.
• While not built into your ESUs, Shielded AEM
®
Instrumentation and Monitors are compatible
with existing generators, delivering new levels
of surgical safety.
AEM
®
Technology for ensuring the safety of your
Y
A
References:
1. Recommendations
to Reduce Surgical Fires and Related Patient Injury: FDA Safety Communication:
Contact Encision for a no risk consultation at 303-444-2600 or info@
t Let Stray Energy Bite Your Surgical O Outcomes
patients.
@encision.com
g y p
g j y e y
https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm608637.htm. Accessed May 29, 2018
2. Martin, Moore, Tucker, Fuchshuber, Robinson. Quantifying Inadvertent Thermal Bowel Injury from the Monopolar Instrument. The Journal of Surgical Endoscopy. November 2016.
3. Cassaro, Sebastiano. Delayed Manifestation of Laparoscopic Bowel Injury. The American Surgeon Journal. May 2015. 2015(81); 478-482.
4. Complete references available at www.encision.com
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