[2912888]
After performing a hysteroscopy and polypectomy, the surgeon proceeded to the ablation. During the ablation, the cavity assessment failed twice. Dr then asked for the thermachoice device. The thermachoice device was attached to the machine in the appropriate manner, primed with 10cc room temperature d5w and then handed to dr to begin the procedure. Dr inserted the device, began instilling the 30cc of d5w until the machine signaled to start the ablation process. The start button was pressed and the ablation began. The machine alarmed several times to alert that the temperature was dropping, but did not fault or stop the procedure. With less than one minute remaining, dr stated that the balloon had burst and pulled the device out of the patient. The surgeon was concerned about the patient and general surgery was consulted. Dr reinserted the hysteroscope and retrieved a portion of the balloon from the thermachoice device. General surgery consulted and determined that the best course of action would be to admit and monitor the patient. The doctor who operated noted that the patient's vagina was reddened and applied silvadene cream to the area. Patient taken to recovery unit in stable condition. Additional information from the surgeon's report: "thermachoice ablation was carried out by starting with an operating pressure of 165; the pressure was stabilized at that point. Treatment cycle was carried out for 7 minutes and 30 seconds, and at the 7 minutes and 30 seconds mark. The device began demonstrating some warnings that the temperature was too low. No additional fluid had changed; had been added or removed and approximately at this time, i noticed some steam coming from the cervical os. The thermachoice probed was immediately removed. It was noted that the thermachoice balloon was not attached to the thermachoice probe. There was noted to be a large amount of balloon fluid that had poured from the cervical cavity scalding the vagina and there was noted to be 3 areas of scalding in the vaginal vault. The hysteroscope was immediately placed into the uterine cavity and the balloon was noted to be at the fundus of the uterus and it was removed with polyp forceps. At this point, because of concerns of the potential for thermal injury in the patient's abdominal cavity, i consulted general surgery; after discussion with them, we felt that the immediate risk was low for a thermal injury to her abdominal cavity given that the temperature at the time of the balloon popping was registering on the machine to be 80 degrees and the low likelihood of uterine perforation. The decision was made to complete the procedure and monitor the patient as an inpatient for development of signs of increased pain or other signs of a thermal injury. "endometriosis ablation complicated by rupture of thermachoice balloon leading to vaginal scalding. Controlled with silvadene and lidocaine jelly. No staging of burns. Other results from this event were extended length of stay. Patient was discharged on post operative day #2 instead of going home the same day of the procedure. Patient experienced pain as a result of the event and recieived surgical consult. No other medical treatments. ======================manufacturer response for thermachoice device, (brand not provided) (per site reporter). ======================they would like the equipment returned in order to perform quality testing. ======================manufacturer response for thermachoice balloon, (brand not provided) (per site reporter). ======================they would like the equipment returned in order to perform quality testing.
Patient Sequence No: 1, Text Type: D, B5