The present motor control unit with the serial number (b)(4) originates from batch 1320301 and was created on (b)(6) 2016 in a lot size of 6 pieces to the new goods warehouse and richard wolf usa at the 08.
08.
2016 delivered.
The review of the throughput plan did not reveal any anomalies.
The motor control unit is used in conjunction with a motor handle.
(e.
G.
Power stick m4) to drive richard wolf rotary knives/ milling cutters for the removal of tissue during endoscopic procedures.
One simultaneous extraction allows the continuous removal of the of worn tissue.
The inspection of the motor control unit revealed that the customer complaint can be traced.
The ek motor control unit board 64352047 is defective.
The cause of this failure is due to a sporadic defect.
The evaluation of the available information does not lead to a direct patient risk, as the product is not suitable for the functional impairment cannot be applied.
In the rule, the user recognizes during the visual and functional check whether damage or function-relevant defects are present.
The ga-a202 operating instructions contain sufficient information on the visible and function control, as well as application and handling.
Among other things, the products must also be available with regard to missing parts as well as damages or functional impairments before and after each application can be controlled.
In order to avoid dangers for users, patients and to keep third parties away.
Hazards due to manufacturing and handling which can lead to functional impairments have been taken into account in the risk assessment.
And assessed with an acceptable risk.
These however, valuations represent the worst-case scenario and are not this is comparable to the complaint described above.
This case is considered closed, however, in the event that additional information is obtained, a follow up report will be submitted to fda.
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