CHANNEL CLEANING BRUSH

Additional Manufacturer Narrative

E1: (B)(6). 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 CLEANING BRUSH HEAD HAD FRACTURED INSIDE THE FORCEPS CHANNEL. THIS MALFUNCTION OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.