It was reported that the patient was unable to manipulate the inflatable penile prosthesis (ipp) pump to achieve an erection as the pump was placed incorrectly.The device had stopped working due to fluid loss.The patient experienced pain, swelling, and erosion in the glans.Upon explant it was found the cylinder tubes were wrapped around the urethra with significant crossover.The ipp was not replaced.No further patient complications were reported.
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There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
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