LIGHTFORCE

Additional Manufacturer Narrative

DEVICE RETURNED FOR EVALUATION AND NO QUALITY ISSUES FOUND. DEVICE SAFETY FUNCTIONS AND PERFORMANCE WERE WITHIN SPECIFICATIONS. REPORTED INJURY CAUSED BY KNOWN RISK INHERENT WITH DEVICE TYPE AND DOCUMENTED IN LABELING AND RISK MANAGEMENT. INCIDENT TYPE WILL BE FURTHER ANALYZED THROUGH POST MARKET SURVEILLANCE PROCESS.

Description of Event or Problem

PATIENT EXPERIENCED LESION ON SHOULDER SEVERAL DAYS AFTER TREATMENT DUE TO INCORRECT PROCEDURE BY OPERATOR. THE PROVIDED DOSE WAS GREATER THAN THE RECOMMENDED LEVEL LEADING TO OVEREXPOSURE. TREATMENT TECHNIQUE DID NOT FOLLOW IFU. ALSO, PATIENT HAD REDUCED SENSATION DUE TO EXISTING CONDITION THAT WAS NOT DISCLOSED PRIOR TO TREATMENT.