HF-RESECTION ELECTRODE "PLASMALOOP", SMALL LOOP, 24 FR., 12°-30°, IN SALINE

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 HF-RESECTION ELECTRODE LOOP WAS POORLY BENT. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.