Investigation summary: with all the available information, boston scientific was unable to confirm the reported pain, the device performed within specifications.The reported patient symptom is a known risk associated with spectra penile prosthesis and is noted as such in the device instructions for use.Device history record (dhr): the device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Device technical analysis: the (spp) cylinders were visually inspected and examined using a microscope.Both cylinders had sharp instrument/tool damage to the outer tube, which resulted in a hole and exposed metal segments.This damage is consistent with explant damage.Due to this damage being consistent with explant it will be considered a secondary failure.Both cylinders passed the bend test.The cylinders therefore performed within specification.Product analysis was unable to confirm the reported event.Labeling review: the device instructions for use (ifu) was reviewed.The patient symptom of pain was found to be listed in the ifu.Investigation conclusion: based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
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