The reported event was confirmed, however the cause was unknown.Visual inspection noted that one opened 100 cc silicone evacuator was received without the original packaging.Visual evaluation noted that the cap was missing on return.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure mode could be due to incorrect operation of assembly/ positioning of components/ accessories.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labelling review was not performed due to the labeling could not have prevented the reported failure.
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