BIPOLAR CUTTING LOOP

Additional Manufacturer Narrative

THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

"THE FOLLOWING WAS REPORTED: "THE SURGEON WAS PERFORMING AN ENDOMETRIECTOMY (A RESECTION OF SOFT TISSUE, NOT A HARD STRUCTURE LIKE A FIBROID), AND THE LOOP BROKE THREE TIMES INSIDE THE UTERUS. THE SURGEON LEFT THE OPERATING ROOM TO RETRIEVE A BETOCCHI HYSTEROSCOPE SET, AS IT CONTAINS FORCEPS THAT ALLOW RETRIEVAL OF THE METAL FRAGMENT LEFT INSIDE THE UTERUS. THE PROCEDURE CONTINUED WITH THE SAME HYSTEROSCOPE AFTER CHANGING THE LOOP THREE TIMES (EACH ONE BREAKING AGAIN), DUE TO DIFFICULTIES IN OBTAINING ADDITIONAL HYSTEROSCOPE SETS THAT DAY, AS THEY WERE STILL IN THE STERILIZATION PROCESS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.".