(b)(6).It was reported that during surgery the tube bloated, but did not burst.All med watch submissions related to this report are: 9610612-2017-00534, 9610612-2017-00535, 9610612-2017-00359, 9610612-2017-00383, 9610612-2017-00391.
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Investigation: a detailed failure analysis could not take place.The hose burst approximately 10cm from the motor.Functionally, the motor, air plug, and the hose are in order.At the fractured positions, no mechanical damages (bruises, cuts) can be found.However, fragments are missing.A complete reconstruction is not possible.The hose is greasy/oily.Most likely, a correct circulation of the exhaust air was not completely possible during use, which led to the burst of the hose.A limitation of the exhaust air can occur due to a incorrect fixation of the hose or due to a kinking of the hose.Batch history review: the device history files for the above mentioned lot numbers have been checked and found to be according to the specification valid at the time of production.There is no indication for a manufacturing failure.Conclusion and root cause: on the basis of the current investigation results, we assume that the most likely cause was a handling error that led to the described failure patterns.No capa is necessary.
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