Model Number 72404310 |
Device Problem
Collapse (1099)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/09/2020 |
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 dimpled pump with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.
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Event Description
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It was reported that the patient underwent a revision procedure due to dimpled pump with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.
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Manufacturer Narrative
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Device analysis: the returned device was analyzed and the reported allegations of dimpled pump was confirmed.Based on a review of all available information, the cause of the reported event was determined to be due to pump malfunction.During analysis the pump failed the activation test.Based on this investigation, the investigation conclusion code of cause traced to component failure was chosen because the reported events could be traced to a component failure through product investigation.Based on the results of this investigation, no escalation is required.
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Event Description
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It was reported that the patient underwent a revision procedure due to dimpled pump with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.
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Manufacturer Narrative
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Device analysis: the returned device was analyzed and the reported allegations of dimpled pump was confirmed.Based on a review of all available information, the cause of the reported event was determined to be due to pump malfunction.During analysis the pump failed the activation test.Based on this investigation, the investigation conclusion code of cause traced to component failure was chosen because the reported events could be traced to a component failure through product investigation.Based on the results of this investigation, no escalation is required.
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Search Alerts/Recalls
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