Description of Event or Problem · 1
PATIENT WAS SEEN FOR NOVASURE ENDOMETRIAL ABLATION. HYSTEROSCOPE WAS PLACED INTO THE ENDOMETRIAL CAVITY, AFTER SOUNDING THE CAVITY WAS FOUND TO BE 8CM WITH A 4CM CAVITY WIDTH. PICTURES WERE TAKEN AS NORMAL-APPEARING ENDOMETRIAL CAVITY. THE NOVASURE DEVICE WAS INSERTED AND OPENED 2.7CM AND CAVITY ASSESSMENT WAS PERFORMED, WHICH PASSED AND THE PROCEDURE WAS PERFORMED. THE ABLATION WAS PERFORMED WITHOUT DIFFICULTY. DURING FOLLOW UP POST-PROCEDURE, THE CAVITY APPEARED TO HAVE A GOOD BURN; HOWEVER, A SMALL PERFORATION WAS NOTED AT THE TOP OF THE FUNDUS ON THE LEFT SIDE. NO BLEEDING WAS NOTED AND NO EVIDENCE OF ANY OTHER ABNORMALITIES. PATIENT WAS RECOVERED AND DID NOT REQUIRE ANY ADDITIONAL TREATMENT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE THREE POINTS ON THE END OF THE DEVICE ARE NOT SHARP PER SAY BUT SEEM TO PENETRATE THE WALL VERY EASILY. THIS IS THE THIRD EVENT WITH THIS TYPE OF DEVICE WHICH RESULTED IN A PUNCTURE IN TWO CASES AND A BURN THROUGH IN ONE CASE (FDA REPORTS ALSO FILED ON THOSE CASES.)====================== MANUFACTURER RESPONSE FOR ENDOMETRIAL ABLATION DISPOSABLE DEVICE KIT, NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION DISPOSABLE DEVICE KIT======================THE NOVASURE REPRESENTATIVE HAS BEEN RESPONSIVE AND HELPFUL IN THIS MATTER.