VENUS BLISS MAX

Description of Event or Problem

THE TECHNICAL SUPPORT TEAM HAD RECEIVED A CALL REGARDING SLOW/NO HEATING OF THE DIODE IN THE VENUS BLISSMAX DEVICE (B)(4), THE CLINICAL TEAM AND FSE VISIT WAS SCHEDULED TO INVESTIGATE AND ANALYZE THE ISSUE. DURING INTERNAL TROUBLESHOOTING OF A VENUS BLISS MAX DEVICE, ENGINEERING STAFF OBSERVED SMOKE COMING FROM THE FIBER CORD CONNECTING THE BODY LASER APPLICATOR NO. 2 TO THE MAIN UNIT. THE TREATMENT WAS SWITCHED TO STANDBY, AND THE EMERGENCY STOP BUTTON WAS PRESSED. A SMALL HOLE AND LOCALIZED MELTING WERE OBSERVED ON THE SILICONE/RUBBER SURFACE OF THE CORD. AFTER 10 MINUTES, THE ENGINEER TOOK OFF THE MAIN PANEL AND TESTED APPLICATOR NO. 1., 3., AND 4., AND OBSERVED THAT THEY WERE WORKING FINE. NO PATIENTS OR USERS WERE HARMED. INVESTIGATION REVEALED THE APPLICATOR CABLE NO. 2 WAS TWISTED AND KINKED IN A MANNER INCONSISTENT WITH IFU GUIDELINES. DEVICE WAS REMOVED FROM SERVICE, REPLACED, AND A REFRESHER TRAINING ON HOW TO PROPERLY HANDLE THE CORDS WHEN PUTTING BACK WAS PROVIDED. A DHR REVIEW SHOWED NO PRODUCTION NONCONFORMITIES. ROOT CAUSE IS ATTRIBUTED TO IMPROPER CABLE HANDLING. ALTHOUGH NO INJURY OCCURRED, THE MALFUNCTION COULD LEAD TO BURNS OR OTHER INJURY DURING PATIENT USE AND IS BEING REPORTED AS A POTENTIAL SERIOUS MALFUNCTION.