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On march 30, 2026, parkell, inc.Was notified of an adverse event involving an ultrasonic scaler (manufactured july 2025).The healthcare provider reported that the device overheated during a procedure, resulting in a patient burn.According to the reporter, the patient did not seek additional medical treatment following the incident.The user noted that this specific unit (s/n (b)(6)) had been returned for service on two prior occasions for reported overheating.Records indicate that previous service evaluations identified the root cause of those instances as an inadequate water supply rather than a mechanical defect.The device was returned to the manufacturer on april 7, 2026, and submitted to the engineering team for a formal evaluation.Comprehensive testing confirmed that the unit is currently functioning within all established original specifications.The investigation identified no hardware malfunctions or electrical faults that would cause the unit to exceed safe temperature thresholds under normal operating conditions.The engineering assessment concluded that the reported overheating was likely secondary to user technique.Specifically, the investigation determined that excessive heat generation was the result of insufficient water volume during operation.There was no evidence of a device-related mechanical failure.The manufacturer is filing this report in compliance with 21 cfr part 803 requirements.While the device was found to be performing as intended, this report is being submitted due to the reported patient injury.
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