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 07/31/2019 |
Event Type
Injury
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Event Description
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It was reported that the patient had the inflatable penile prosthesis pump component removed due to a dimpled pump.A new inflatable penile prosthesis pump was implanted.Further information was requested and not yet received.Should additional relevant details become available, a supplemental report will be submitted.Additional information received indicated the physician was unable to determine the reason for the dimpled pump.The patient pressed the pump, but then it stayed flat.The onset of the event leading to the revision surgery was 2 weeks ahead of the surgery.The patient outcome was that the patient got well.
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Manufacturer Narrative
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Device evaluation: the complaint component was returned and analyzed.The reported allegation of malfunction was confirmed via product analysis of the pump.The pump was not functionally tested due to the misaligned spring.The allegation of pump malfunction was confirmed as the misaligned spring would affect pump performance.No escalation to ncep, capa, or scar is required.
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Event Description
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It was reported that the patient had the inflatable penile prosthesis pump component removed due to a dimpled pump.A new inflatable penile prosthesis pump was implanted.Further information was requested and not yet received.Should additional relevant details become available, a supplemental report will be submitted.Additional information received indicated the physician was unable to determine the reason for the dimpled pump.The patient pressed the pump, but then it stayed flat.The onset of the event leading to the revision surgery was 2 weeks ahead of the surgery.The patient outcome was that the patient got well.
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Search Alerts/Recalls
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