HF-RESECTION ELECTRODE "PLASMAROLLER", ROLLER, 24 FR., 12°-30°, ESG TCRIS

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 DETACHMENT OF THE ELECTRODE TIP. THE ISSUE WAS FOUND DURING TRANSURETHRAL RESECTION OF THE PROSTATE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.