ELLACOR SYSTEM WITH MICRO-CORING TECHNOLOGY

Description of Event or Problem

IT WAS REPORTED THAT TREATMENT WAS COMPLETED AFTER DEVICE SERVICED (B)(6) 2023. OFFICE STATES THE GRID PATTERNS WERE NOT HOW THEY NORMALLY APPEAR, AND THE PATIENT ENDED UP HAVING A LACERATION ON HER CHIN DUE TO THE NEEDLESS. SUTURING WAS REQUIRED AND PROLONGED COMPRESSION.

Additional Manufacturer Narrative

THE HANDPIECE UNDER INVESTIGATION, HP-187, WAS RECEIVED AT CYTRELLIS ON (B)(6) 2023 AND WAS DEEMED INOPERABLE UPON ARRIVAL. UPON FURTHER INVESTIGATION, TWO ISSUES WERE IDENTIFIED- A) EVIDENCE OF BROKEN COMPONENTS ON HANDPIECE PCB . THIS ISSUE, IF OCCURRED DURING THE PROCEDURE, WOULD HAVE RENDERED THE HANDPIECE COMPLETELY INOPERABLE (COMPLETE POWER SHUT DOWN) AND NOT BEEN ABLE TO CONTINUE AND COMPLETE THE PROCEDURE (WHICH IT DID). B) EVIDENCE OF BROKEN GLUE BONDS. REVIEW OF IOT DATA CONFIRMED NO SYSTEM-REPORTED ERRORS DURING THE PROCEDURE. MOREOVER, IF GLUE BONDS DID BREAK DURING THE PROCEDURE IN WHICH THIS ADVERSE EVENT OCCURRED AND FOR SOME IMPOSSIBLE REASON, DID NOT GET DETECTED, THE HANDPIECE WOULD HAVE BEEN IN NO STATE TO CONTINUE TO LAY PATTERNS AND COMPLETE THE PROCEDURE. AS SUCH, THERE IS NO EVIDENCE THAT POINTS TO THE HANDPIECE AS A CONTRIBUTING FACTOR TO THIS ADVERSE EVENT. NO FURTHER ACTION IS REQUIRED. CYTRELLIS TEAM HAS SINCE THEN SERVICED THIS HANDPIECE AND IT'S CURRENTLY OPERATIONAL AND MEETS OUR PRODUCT SPECIFICATIONS. PER OUR POLICY, WE WILL CONTINUE TO MONITOR AND ASSESS ALL COMPLAINTS AND ASSOCIATED DATA TO MAKE THE BEST DECISIONS FOR OUR CUSTOMERS.