Model Number 72404310 |
Device Problems
Collapse (1099); Mechanical Problem (1384)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/09/2020 |
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 the device not working properly two weeks prior to the revision procedure with an inflatable penile prosthesis (ipp).Diagnostic testing found that when the pump was pressed it was difficult to press.The ipp pump was explanted and a new ipp pump was implanted.The patient was stable following the procedure.
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Manufacturer Narrative
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The returned device was analyzed and the reported allegations of a pump malfunction was confirmed.Based on a review of all available information, the cause of the reported event was due to the pump failing the activation test.
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Event Description
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It was reported that the patient underwent a revision procedure due to the device not working properly two weeks prior to the revision procedure with an inflatable penile prosthesis (ipp).Diagnostic testing found that when the pump was pressed it was difficult to press.The ipp pump was explanted and a new ipp pump was implanted.The patient was stable following the procedure.
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Search Alerts/Recalls
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