F A C T S H E E T For information contact: Joni Morford, Communicore 714/721-8081 jmorford@communicore.com PREVENTING LAPAROSCOPIC ELECTROSURGICAL INJURY Facts About Minimally Invasive Surgery and Monopolar Electrosurgical Technique * Minimally invasive surgery is estimated to account for 15 percent of all surgeries that take place each year in the United States * Minimally invasive surgery is expected to account for 40 percent of all urological, 50 percent of all general, and 70 percent of all gynecological procedures by the year 2000 * Monopolar electrosurgery is regarded by 80 percent of surgeons as the most effective technique available for cutting and coagulation (clotting) of tissue during minimally invasive surgery * Due to a limited field of vision during minimally invasive surgery, surgeons cannot see 90 percent of the live electrode during monopolar electrosurgery * Monopolar electrosurgery has the potential to cause unintended electrical burn injuries to surrounding non-targeted tissues and organs Facts About Minimally Invasive Electrosurgical Injury * Burns to non-targeted sites caused by stray electrical energy during monopolar electrosurgery can cause peritonitis, organ perforation, hemorrhaging, and death * Since burns usually occur outside of the surgeon's field of view through the laparoscope, they can go undetected until days after surgery, when serious burns may have caused severe infection requiring emergency treatment * Additional surgery is the most common treatment for electrosurgical injury * A survey of surgeons at the American College of Surgeons annual meeting in 1993 reported that 18 percent of the 506 surgeons polled responded that they had personally experienced complications during minimally invasive surgery due to the release of stray electrical energy, and 54 percent knew of another surgeon who had Facts About Legal Liability Associated with Minimally Invasive Electrosurgery * Of the 1 million minimally invasive procedures conducted in 1993, 600 patients claimed injury; 35 of these injuries led to patient death, many from perforated bowels * In 70 percent of laparoscopic malpractice claims, injuries are not detected until after the patient goes home from surgery * Since 1985, $385 million in jury awards have been paid to patients injured during minimally invasive surgery * The average indemnity per case was $130,000 Facts about ElectroScope's Electroshield Monitoring System¨ * ElectroScope's Electroshield Monitoring System¨ is the only available product that completely eliminates the risk of injury due to stray electrical energy during monopolar electrosurgery * The Electroshield Monitoring System is "transparent" to the user and requires minimal additional training for surgeon or staff * Electroshield instruments are priced comparably to other manufacturers' reusable instruments, and on a cost-per-use basis are less expensive than disposable electrodes * The Emergency Care Research Institute (ECRI), an independent, non-profit research agency that reviews and tests medical devices, has recommended the Electroshield Monitoring System as the highest level protection available against patient injury due to insulation failure and capacitive coupling End of document.