Description of Event or Problem · 0
IT WAS REPORTED THAT A PATIENT EXPERIENCED A BURN ON THE CHEST AND PROVIDER SAW RED SPARKS COMING FROM THE EFFECTOR DURING A XERF TREATMENT. EFFECTOR WAS REPLACED AND TREATMENT WAS COMPLETED WITHOUT ANY OTHER ISSUES. A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM CONTACTED THE TREATMENT PROVIDER FOR ADDITIONAL INFORMATION. PATIENT EXPERIENCED ERYTHEMA AND BLISTERS 30 MINUTES AFTER TREATMENT WAS PERFORMED. SITE PROVIDER REPORTED THAT 41 PULSES WERE DELIVERED AT LEVEL 8, ICD LEVEL 3, WHEN THEY OBSERVED RED SPARKS ORIGINATING FROM THE EFFECTOR SURFACE IN CONTACT WITH THE PATIENT'S SKIN. THE EFFECTOR WAS SUBSEQUENTLY REPLACED, AND THE TREATMENT WAS COMPLETED WITHOUT FURTHER INCIDENT. PROVIDER CONFIRMED THAT AN ADEQUATE AMOUNT OF ULTRASOUND GEL WAS APPLIED TO THE TREATMENT AREA, AND THAT BOTH HANDPIECE PERPENDICULARITY AND SKIN CONTACT WERE MAINTAINED APPROPRIATELY THROUGHOUT THE PROCEDURE. PROVIDER COULD NOT CONFIRM THE TOTAL NUMBER OF PULSES PERFORMED OR THE TOTAL ENERGY DELIVERED ON THE TREATMENT AREA AT THE END OF TREATMENT. BASED ON THE INFORMATION AVAILABLE, THE ROOT CAUSE OF THE REPORTED SIDE EFFECTS CANNOT BE DETERMINED. BURNS, ERYTHEMA, AND BLISTERS ARE EXPECTED SIDE EFFECTS FROM SUCH TREATMENTS. TREATMENT SETTINGS AND TECHNIQUE WERE DISCUSSED IN DETAIL WITH PROVIDER. COMPLIMENTARY HANDS-ON REFRESHER TRAINING WAS OFFERED TO THE SITE. PROVIDER TOOK OFFENSE AND STATED THAT THEIR TREATMENT TECHNIQUE DOES NOT REQUIRE IMPROVEMENT. VIRTUAL TRAINING WAS REQUESTED INSTEAD. A CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) ARRIVED AT THE SITE TO EVALUATE THE DEVICE. THE UNIT WAS CALIBRATED AND DA VALUES WERE ADJUSTED. COILS INSIDE THE MATCHER BOARD WERE INSULATED TO PREVENT ANY CURRENT LOSS. DEVICE CONFIRMED TO MEET PUBLISHED SPECIFICATIONS. CYNOSURE LUTRONIC TECH SUPPORT REACHED OUT TO THE SITE FOR THE EFFECTOR TIP TO BE RETURNED FOR EVALUATION. ROOT CAUSE FOR SPARK CAN BE DETERMINED AFTER TIP HAS BEEN RECEIVED AND EVALUATED. THE EVENT IS REPORTABLE PER FDA MEDICAL DEVICE REPORTING TITLE 21 CFR PART 803 SINCE A MALFUNCTION OCCURRED AND WOULD LIKELY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. WE ARE REPORTING THIS AS AN INITIAL MDR AND WILL SUBMIT A FINAL MDR ONCE INVESTIGATION HAS BEEN COMPLETED.