ELLACOR SYSTEM WITH MICRO-CORING TECHNOLOGY

Description of Event or Problem

IT WAS REPORTED TO THE COMPANY THAT A TRAINED CLINICIAN TREATED A PATIENT WITH THE ELLACOR SYSTEM (B)(6) 2023. THE COMPANY WAS NOTIFIED ON (B)(6) 2023 THAT THE PATIENT'S RIGHT ORAL COMMISSURE/NASOLABIAL AREA APPEARS TO HAVE TEXTURAL CHANGES AND DISCOLORATION POST TREATMENT AT 24 DAYS.

Additional Manufacturer Narrative

THE HANDPIECE RELATED TO ADVERSE EVENT WAS THOROUGHLY TESTED, RUNNING SEVERAL PATTERNS AT ALL DENSITIES AND DEPTH SETTINGS AND IN MULTIPLE HANDPIECE ORIENTATIONS. NO PATTERN ISSUES WERE OBSERVED. NOTHING WAS FOUND TO BE DISCREPANT WITH THIS HANDPIECE OR IN THE HANDPIECE DESIGN. THE CAUSE WAS IDENTIFIED AS USER ERROR DUE TO PUSHING ON THE NEEDLE TUBING DURING A PATTERN. THIS MAY OCCUR INADVERTENTLY IF THE USER RESTS THIS TUBING AGAINST THEIR HAND OR THE PATIENT'S FACE WHILE PUNCHING. THIS WAS THE ONLY WAY THE FAILURE MODE (IRREGULAR PUNCH PATTERN) COULD BE REPLICATED. THE PRIMARY ROOT CAUSE WAS DETERMINED TO BE RELATED TO TRAINING AND INCOMPLETE IFU.