The investigation has been completed.A device history record (dhr) review was performed and found no non-conformances that would cause the reported malfunction.All records indicate that the device was manufactured in accordance with all applicable procedures.The instructions for use (ifu) states: ¿before using the equipment, always check that there is no irregularity regarding the following points on the lid and the lid packing.If there is any irregularity, cleaning fluid or disinfectant solution may leak out.¿ the root cause could not be conclusively determined.Probable causes that could have led to the reported event include the lid being contacted with a scope when it was closed and/or something hard hit the lid and/or chemical crack due to adhered chemical solution which was not removed.
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