There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The cylinders being too short for the patient anatomy could have caused or contributed to the reported patient symptom of floppy glans, which is a known risk associated with implant of these devices as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of unintended use error caused or contributed to event was assigned to this investigation as the event was determined to be unintentional or inadvertent interaction.
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