HF-RESECTION ELECTRODE "PLASMALOOP ¿ MEDIUM, 30°", 24 FR., STANDARD, 12°-30°

Description of Event or Problem

IT WAS REPORTED THAT DURING A HYSTEROSCOPIC SUBMUCOSAL MYOMECTOMY, THE ELECTRODE WAS DAMAGED AND FELL OFF INTO THE UTERUS. THE FALLEN OFF PIECE WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ELECTRODE DEVICE, RESULTING IN A DELAY OF ABOUT 30 MINUTES. A REOPERATION WAS PERFORMED AT AN UNKNOWN TIME, AND PERFORATION OF THE UTERUS WAS CONFIRMED. THE CUSTOMER REPORTED THAT IT WAS UNCLEAR WHETHER THE REOPERATION WAS CAUSED BY THE DAMAGED ELECTRODE. REPORT 1 OF 2.

Additional Manufacturer Narrative

E1: ESTABLISHMENT NAME: (B)(6). E1: ESTABLISHMENT ADDRESS: (B)(6). THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND CONFIRMED THE REPORTED PROBLEM: A VISUAL INSPECTION FOUND THAT THE LOOP ELECTRODE AT THE TIP HAD BROKEN. THE CAUSE OF THE LOOP ELECTRODE BREAKAGE CANNOT BE IDENTIFIED, BUT INSPECTION OF THE FRACTURE SURFACE SUGGESTS THAT IT MAY HAVE BEEN CAUSED BY OVERLOAD. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: COMPONENT FAILURE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER, BUT NO FURTHER INFORMATION HAS BEEN RECEIVED AT THIS TIME. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.