Model Number 72404310 |
Device Problems
Fluid/Blood Leak (1250); Inflation Problem (1310); Loose or Intermittent Connection (1371)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/10/2019 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a revision procedure due to right connector disorder with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.Additional information was reported there was a crack and fluid loss at the connector, the patient had difficulty inflating device, and the patient recovered following the procedure.
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Event Description
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It was reported that the patient underwent a revision procedure due to right connector disorder with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.Additional information was reported there was a crack and fluid loss at the connector, the patient had difficulty inflating device, and the patient recovered following the procedure.
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Manufacturer Narrative
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Device analysis: product analysis could not confirm the reported events as pump contamination was present resulting in an inability to functionally test the pump.A leak test was performed and no leaks were identified.No connectors returned; the allegation of "connector disorder" could not be confirmed.Based on this investigation, the investigation conclusion code of cause not established was chosen because the reported events could not be confirmed or substantiated through investigation of the pump component and the connectors did not return.Based on the results of this investigation, no escalation is required.
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Search Alerts/Recalls
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