Model Number 72404232 |
Device Problems
Collapse (1099); Inflation Problem (1310)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/09/2020 |
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 as the pump remained flat and filled the implant with difficulty.The reservoir was full.The pump was tested on the table and once implanted, the implant worked well.
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Manufacturer Narrative
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D10, h3, h6, h10.H3 device evaluation: the ams 700 momentary squeeze (ms) pump was visually inspected; no leaks were found.The pump was functionally tested and performed within specification.Product analysis was unable to confirm the reported events.
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Event Description
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It was reported that the patient had the inflatable penile prosthesis pump component removed as the pump remained flat and filled the implant with difficulty.The reservoir was full.The pump was tested on the table and once implanted, the implant worked well.
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Search Alerts/Recalls
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