The evaluation of the returned products, e-sogen-or and som-hp, was completed on (b)(6) 2021.Functionality was confirmed as per our (b)(4) bone scalpel and sonicone or hp test data work instructions.The device was evaluated, inspected and concluded with no problem found.The system is designed to emit alarms/faults when there is an anomaly with the device, such as improper assembly or use.It is unclear from the report whether irrigant was at the tip at the onset of vibratory activation.The instructions for use manual, e-soum-or, provides adequate instructions for performing set up prior to use.The instructions for use section 7 warnings for the sonicone o.R.System includes the following warnings: caution 7.7: prime the irrigation tubing prior to use.At all times ensure that the irrigant flows towards the handpiece when footswitch is depressed.If no irrigant is flow, cease use until flow is restored warning 7.3: tip and irrigation temperatures may exceed the tissue necrosis point with sonicone o.R.Accessories for hard tissue removal if insufficient irrigation flow rates are used.Always set the irrigation flowrate for hard tissue removal to a setting no less than the comparable vibration setting.For esample, if the vibration setting is 7, a minimum flow setting of 70% should be used.Warning 7.4: heat is being generated at the tip/tissue interface.A continuous, lateral sweeping montion is recommended for general bone/tissue removal in order to minimize contact duration with the ultrasonic tip and minimize the temperature increase.We cannot determine a definitive root cause.A potential root cause of the burn is that insufficient irrigation flow caused an excess in temperatures, causing the handpiece to increase in heat and burn the patient.Running a blade without the benefit of damping provided by irrigation can result in excessive heat, resulting in the burn.
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