Investigation results: visual investigation: the investigation has been carried-out by the aesculap technical service (ats).Optically, the products are in a used but good condition.Gd450m: the handpiece has been checked according to the internal inspection plan.A visual and function check (e.G.Plug connection, current consumption, temperature, running noises) was performed.The tip is slightly bent and staining could be found inside the interior.However, no functional deviation, no increased heating.Ga824: the motor has been checked according to the internal inspection plan.A visual and function check (e.G.Plug connection, current consumption, temperature, running noises) was performed.No deviation regarding the general function, however, locking bar is damaged, as well as the pins and springs are bent.No increased heating.Ga806: the motor cable has been checked according to the internal inspection plan.A visual and function check (e.G.Plug connection, current consumption, temperature, running noises) was performed.No deviation could be detected.The product is according to the specification, valid at the time of production.Gd460r: the tube of the spray nozzle is strongly deformed and defect.The mentioned failure (heating) could not be confirmed on any of the provided devices.No failure detected which is related to the complaint failure pattern (heating of the handpiece).Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.
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