HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TCRIS

Description of Event or Problem

IT WAS REPORTED THE RESECTION ELECTRODE PLASMA LOOP THE LOOP BROKE OFF INSIDE THE PATIENT. THE ISSUE WAS FOUND DURING A THERAPEUTIC RESECTION OF A FIBROID PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR 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.