CYSTOSCOPE SHEATH, 22 FR.

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: "AFTER INSERTION OF THE CYSTOSCOPE INTO THE BLADDER, THE DISTAL PART DETACHED AND REMAINED INSIDE THE BLADDER. DESPITE ATTEMPTS TO RETRIEVE IT USING A FOREIGN BODY FORCEPS AND A LITHOTRIPSY FORCEPS, IT WAS NECESSARY TO PERFORM A CYSTOTOMY (BLADDER INCISION) TO RECOVER THE DETACHED COMPONENT. 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 5 CM LACERATION WAS FOUND ON THE POSTERIOR ASPECT OF THE LOWER UTERUS, WHICH WAS THE SOURCE OF THE BLEEDING.