ELECTRODE, BIPOLAR

Description of Event or Problem

THE PATIENT UNDERWENT A HYSTEROSCOPIC MYOMECTOMY. AT THE END OF THE PROCEDURE, THE TIP OF THE HYSTEROSCOPE BROKE (A FRAGMENT CONSISTING OF WHITE PLASTIC AND A METALLIC PART). THE LOOP WAS CHANGED, AND AN ATTEMPT WAS MADE TO RETRIEVE THE FRAGMENT USING THE PROCEDURE WAS STOPPED BECAUSE OF THE PATIENT'S HEMODYNAMIC INSTABILITY. AFTER PLACEMENT OF A FEMORAL CATHETER, A LAPAROSCOPY WAS PERFORMED FOR ABDOMINAL EXPLORATION. MORE THAN 6 LITERS OF HYSTEROSCOPIC FLUID WERE ASPIRATED, FOLLOWED BY CLOTTING BLOOD. A DECISION WAS MADE TO CONVERT TO A PFANNENSTIEL LAPAROTOMY. THE BLOOD WAS ASPIRATED, AND THE 2 CM METALLIC FRAGMENT OF THE LOOP WAS RETRIEVED FROM INSIDE THE UTERUS. THE UTERINE LACERATION WAS CLOSED WITH X-SHAPED SUTURES TO ACHIEVE HEMOSTASIS. IN TOTAL, THE PATIENT RECEIVED TRANSFUSION OF 6 UNITS OF RED BLOOD CELLS, 3 UNITS OF FRESH FROZEN PLASMA, AND 2 UNITS OF FIBRINOGEN. CROSS REFERENCE MDR: 9610617-2026-26-521, 9610617-2026-26-522.

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).