Description of Event or Problem · 1
MEA PROCEDURE PERFORMED IN 2005 IN A UTERINE CAVITY CONFIRMED TO BE 11 CM IN LENGTH. A 5 CM SUBMUCOSAL FUNDAL FIBROID WAS DOCUMENTED AND ITS PRESENCE WAS VISUALLY CONFIRMED PRIOR TO TREATMENT. TWO CONSECTIVE MEA TREAMENTS WERE PERFORMED. THE FIRST CONSISTED OF A FULL 8 MINUTES TREATMENT OF PART OF THE UTERINE CAVITY. THE SECOND CONSISTED OF A 2.5 MINUTE TREATMENT PERFORMED TO COMPLETION FOLLOWING FURTHER HYSTEROSCOPY AND REINSERTION OF THE APPLICATOR. PATIENT PRESENTED TO THE HOSPITAL ONE DAY POST-TREATMENT WITH PERSISTENT NAUSEA, VOMITING AND LOW GRADE FEVER. INITIAL TREATMENT CONSISTED OF ANITIBIOTIC AND HYDRATION THERAPY. TWO DAYS POST-TREATMENT, A CT SCAN WAS PERFORMED AND RESULTS WERE NORMAL. FIVE DAYS POST TREATMENT, EXPLORATORY LAPAROTOMY OF THE PELVIS WAS PERFORMED AND THIS EXAMINATION REVEALED THAT SOME ADHESIONS WERE INTERMITTENTLY PRESENT BETWEEN THE SIGMOID COLON, THE UTERUS, THE RIGHT ADNEXA, AND THE APENDIX. UPON SEPARATION OF THE SPECIFIC SECTION OF RIGHT POSTERIOR FUNDUS WERE OBSERVED. THERE WAS NO BOWEL INJURY PRESENT, AND IT IS UNKNOWN HOW/WHEN THE UTERINE PERFORATION OCCURRED. A HYSTERECTOMY AND REMOVAL OF RIGHT ADNEXA WAS PERFORMED AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THERE WA SALSO NO REPORT OF AN DEVICE MALFUNCTION OR PERFORMANCE DEVIATION DURING CLINICAL USE.