Model Number 720074-01 |
Device Problem
Inflation Problem (1310)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/13/2018 |
Event Type
Injury
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Event Description
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It was reported that the patient experienced the pump not inflating with a spectra penile prosthesis (spp).The spp was explanted and a new cxr inflatable penile prosthesis (ipp) was implanted.During the implant procedure, the first cylinder that was attempted was not implanted due to measurement error and the cylinder was too thick to advance to the corpus cavernosum and a new ipp cylinder was implanted.Should additional relevant details become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Device analysis: inflation issues were reported.The spectra cylinders were visually inspected and functionally tested.One cylinder performed within specifications.One cylinder had a hole in the outer layer that was the result of tool damage consistent with explant damage.This cylinder was functional.The product record review revealed no additional information related to the complaint so an overall investigation conclusion code of no problem detected was chosen as the reported device problem cannot be confirmed.The reported allegation(s) could not be confirmed.No escalation to ncep, capa, or scar is required, complaints are monitored for escalation of systemic issues through the trending process per the cis product investigation work instruction.
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Event Description
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It was reported that the patient experienced the pump not inflating with a spectra penile prosthesis (spp).The spp was explanted and a new cxr inflatable penile prosthesis (ipp) was implanted.During the implant procedure, the first cylinder that was attempted was not implanted due to measurement error and the cylinder was too thick to advance to the corpus cavernosum and a new ipp cylinder was implanted.Should additional relevant details become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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