One week after a laparoscopic hysterectomy the pt experienced very severe pain. The pt was admitted to the hosp where it was discovered that there was a leak from one of her ureters. A stent was placed to drain the kidney and allow the ureter time to heal. The surgeon believes there was no direct injury at the time of the hysterectomy, but there was lateral thermal injury as a result of the bipolar cautery tripolar cutter that was used for the procedure.

Number of persons - 1 the info for this report was received from a distributor by way of a fax, not a distributor report. According to the surgeon involved in the case, the hysterectomy was completed uneventfully. He feels that the lateral diathermy burn caused a small area of necrosis in the uretic wall. He stated that the pt will experience a complete recovery without any loss of kidney function or other function. A review of the mdr database shows that there were 4 reportable events associated with the seitzinger tripolar cutting forceps since product introduction in august 1994 (a less that 0. 01% incident rate). There were three incidents where a pt injury was reported and one incident where the physician chose to complete the operation via laparotomy. In one of the three pt injuries the ureter was burned. The physician involved in this incident reported there was no malfunction of the instrument and the burn was related to technique. The physician stated that the ureter was burned due to proximity of the tissue to the tongs of the instrument when current was applied. In the other two pt injuries the umbilicus and thigh, respecively were inadvertently burned. The burns to the umbilicus and thigh were associated with plugging the cables into the monopolar output of the generator, rather than the bipolar output.