HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30°

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 THE RESECTION ELECTRODE HAD THE TIP OF THE LOOP WAS BENT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION: IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE REPORTED EVENT IS CAUSED BY A COMPONENT FAILURE. THE CAUSE OF THE DISTAL END DEFORMATION DISCOVERED THROUGH VISUAL INSPECTION COULD NOT BE IDENTIFIED, BUT IT IS BELIEVED POSSIBLE THAT THE DEFORMATION WAS CAUSED BY EXTERNAL OVERLOAD. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.