ELLACOR SYSTEM WITH MICRO-CORING TECHNOLOGY

Additional Manufacturer Narrative

THE HANDPIECE WAS RETURNED FROM FIELD FOR NOT PRODUCING FULL PATTERNS. UPON ARRIVAL THE UNIT WAS TESTED AND FOUND THAT THE UNIT WAS PRODUCING A FULL PATTERN BUT DID NOT SOUND PROPER. THE UNIT WAS OPENED, AND IT WAS NOTICED THAT THE BUSING FOR THE Y STAGE LEAD SCREW WAS NOT PRESENT. THE ID AND OD BOND FOR THE Y STAGE LEAD SCREW WAS NOT INTACT.

Description of Event or Problem

IT WAS REPORTED THAT PHYSICIAN STARTED TREATING PATIENT'S LEFT JAWLINE PROCEDURE AT 8% AND 3.0MM DEPTH. THE SECOND HALF OF THE FIRST PATTERN, AND SECOND PATTERN PRODUCED THREE "CUTS" VS. DOTTED MICRO-CORING PATTERNS. THE NEEDLE CARTRIDGE WAS CHANGED, AND THE THIRD PATTERN WAS BACKED DOWN TO 5% 3.0MM. ONCE AGAIN, THREE "CUTS" WERE MADE WITH THE NEW NEEDLE CARTRIDGE AND SETTING. NEW HANDPIECE USED AND THEY CONTINUED THE PROCEDURE TO COMPLETION OF MID/LOWER FACE. PER DR. MEEK, ALL "CUTS" REQUIRED SUTURING W/RUNNING 6-0 SUTURE (TOTAL OF 9- 0.4" LACERATIONS AND 3-0.2" LACERATIONS).