It was reported that the patient with an inflatable penile prosthesis (ipp) presented with the left cylinder crossed over into the right corpora.The ipp was explanted, and the physician irrigated, redialated, and remeasured the patient.A new ipp was implanted.There were no patient complications reported.
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Despite good faith efforts the lot number of the cylinders could not be confirmed.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.
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