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

Additional Manufacturer Narrative

UPDATED FIELDS E4, H3, H4, H6. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. A ROOT CAUSE WAS IDENTIFIED TO BE COMPONENT FAILURE. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: IT IS POSSIBLE THAT THE ELECTRODE LOOP BREAK COULD HAVE BEEN CAUSED BY AN EXTERNAL OVERLOAD. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "CHAPTER 5 PREPARATION¿. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

IT WAS REPORTED BOTH THE LEFT AND RIGHT SIDES OF THE RESECTION ELECTRODE LOOP CAME OFF. THIS ISSUE OCCURRED DURING A THERAPEUTIC POLYMERASE CHAIN REACTION (PCR) PROCEDURE. THERE WAS NO DELAY, AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED BOTH THE LEFT AND RIGHT SIDES OF THE RESECTION ELECTRODE LOOP CAME OFF. THIS ISSUE OCCURRED DURING A THERAPEUTIC POLYMERASE CHAIN REACTION (PCR) PROCEDURE. THERE WAS NO DELAY, AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.