CMF

Additional Manufacturer Narrative

SEE D9, H3, H6 AND H11 RETURNED PRODUCT INSPECTED AND REPORTED COMPLAINT WAS CONFIRMED "ULTRASONIC HEAD OVERHEATING AND COUNTDOWN ACCELERATION", UPON RECEIVING THE DEFECTIVE PRODUCT, IT DISPLAYED "CONTACT SUPPLIER" WHEN TURNED ON. UPON INITIAL INSPECTION OF THE ULTRASONIC HEAD, IT WAS FOUND THAT THE STICKER WAS WARPED, SUGGESTING IT MAY HAVE BEEN REMOVED AND REAPPLIED. THE SIDE OF THE ULTRASONIC HEAD SHOWED SIGNS OF DEFORMATION DUE TO EXTERNAL FORCE. AFTER RESETTING TO FACTORY SETTINGS, THE PRODUCT STILL EXHIBITED THE OVERHEATING ISSUE REPORTED BY THE CUSTOMER. UPON FURTHER DISASSEMBLY OF THE ULTRASONIC HEAD, IT WAS DISCOVERED THAT A SECTION OF THE ENAMELED WIRE HAD PAINT PEELING OFF. PRELIMINARY ANALYSIS SUGGESTS THAT THE PCBA DEFORMATION AND BULGE CAUSED BY EXTERNAL FORCE RUBBED AGAINST THE ENAMELED WIRE, RESULTING IN PAINT PEELING. THE PAINT PEELING ON THE ENAMELED WIRE WAS LOCATED NEAR THE 9V CAPACITOR CONNECTION, CAUSING AN IC SHORT CIRCUIT AND PREVENTING THE OVERHEAT PROTECTION FUNCTION FROM WORKING, LEADING TO OVERHEATING AND BURNING. INITIAL REPORT 616086-2025-00066 WAS FILED IN RESPONSE TO THE REPORTED EVENT., HOWEVER TECHNICIAN EVALUATION INDICATES INCIDENT IS NOT ATTRIBUTED TO A DESIGN, PRODUCT QUALITY, OR LABELING DEFICIENCY.

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE UNIT IT IS COUNTING DOWN RAPIDLY FROM TWENTY MINUTES AND GETTING SO HOT THAT IT BURNED THE PATIENT. THE PATIENT STATED THE DEVICE LEFT A LARGE BURN ON HER AFTER THE FIRST USE. THE PATIENT WAS TOLD IF THIS DEVICE DID NOT HEAL HER, SHE WOULD HAVE TO HAVE SURGERY, SO SHE ENDURED THE PAIN. THE PATIENT STATED WITHIN A FEW MINUTES OF USING THE DEVICE HEAT UP BUT ALLOWED IT TO CONTINUE TREATING. THE PATIENT STATED ON HER NEXT USE SHE USED MORE GEL, AND SHE FELT IT BURNING AGAIN AND THE COUNTDOWN SEEMED TO GO WAY FASTER THIS TIME AS IF SOMETHING WAS WRONG. THE PATIENT STATED STOPPED USE AND REPORTED IT TO THE REO. THE PATIENT STATED THE DEVICE LEFT A HUGE WOUND. A PICTURE CONFIRMED THE REPORTED INJURY. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, THE ROOT CAUSE COULD NOT BE CONFIRMED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF MORE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THE UNIT IT IS COUNTING DOWN RAPIDLY FROM TWENTY MINUTES AND GETTING SO HOT THAT IT BURNED THE PATIENT. THE PATIENT STATED THE DEVICE LEFT A LARGE BURN ON HER AFTER THE FIRST USE. THE PATIENT WAS TOLD IF THIS DEVICE DID NOT HEAL HER, SHE WOULD HAVE TO HAVE SURGERY, SO SHE ENDURED THE PAIN. THE PATIENT STATED WITHIN A FEW MINUTES OF USING THE DEVICE HEAT UP BUT ALLOWED IT TO CONTINUE TREATING. THE PATIENT STATED ON HER NEXT USE SHE USED MORE GEL, AND SHE FELT IT BURNING AGAIN AND THE COUNTDOWN SEEMED TO GO WAY FASTER THIS TIME AS IF SOMETHING WAS WRONG. THE PATIENT STATED STOPPED USE AND REPORTED IT TO THE REO. THE PATIENT STATED THE DEVICE LEFT A HUGE WOUND. A PICTURE CONFIRMED THE REPORTED INJURY.