Correction/additional information: b5 + d10: involved components; d9: date of device returned to manufacturer; h6: codes.Investigation results: visual investigation: optically, the products are in a used but good condition.The investigation has been carried-out by the aesculap technical service.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.Initially, no deviation could be found.However, after the disassembly, it could be detected that the ball bearing gd450216 is damaged.This may have led to the reported heating.It is possible that an overload situation led to the breakage of the ball bearing due to wear and tear.No indication for a manufacturing of product failure.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, a material throw-up can be found at the locking bar ga824203.This is not related to the complained error.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 deformed and leaking.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.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence 3(5)) according to din en iso 14971 is still acceptable.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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