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Company Applauds FDA Safety Communication

A surgical technology company, Encision Inc., has applauded the FDA’s issuance of a safety communication, “Recommendations to Reduce Surgical Fires and Related Patient Injury: FDA Safety Communication” that describes the dangers of monopolar electrosurgery and the means to mitigate or eliminate this risk.

The Safety Communication was released by the FDA on May 29, 2018 and it may be found on the FDA’s website at:  https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm608637.htm.

The Safety Communication states that, “In addition to serving as an ignition source, monopolar energy use can directly result in unintended patient burns from capacitive coupling and intra-operative insulation failure. If a monopolar electrosurgical units (ESU) is used:

Do not activate when near or in contact with other instruments.”

“Optimizing surgical outcomes and eliminating the sources of potential surgical risk to patients are the primary objectives for all involved in medical devices and surgical care,” said Gregory Trudel, President and CEO of Encision. “We are encouraged by the FDA’s recent safety communication that focuses on the significant patient risks of capacitive coupling and intra-operative insulation failure during standard or robotic laparoscopic surgery. We applaud the FDA’s initiatives to safeguard the public from these potentially deadly sources of patient injury and we promise to complement their efforts by providing accredited continuing education and technical solutions to surgical providers. To the best of our knowledge, AEM® Technology is the only technical solution to this issue.”

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