Model Number 72404310 |
Device Problems
Failure to Cycle (1142); Fluid/Blood Leak (1250); Mechanical Problem (1384); Connection Problem (2900)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/22/2019 |
Event Type
Injury
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Event Description
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It was reported that the patient experienced connector disorder with an inflatable penile prosthesis (ipp).The ipp pump, cylinder, and reservoir was explanted and a new ipp pump, cylinder, and reservoir was implanted.Additional information was reported that the connector did not stay straight in the body and being continuously rubbed against by the skin resulting in the connector being worn down an fluid loss with failure to cycle the device.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.
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Manufacturer Narrative
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Device analysis: a connector disorder and fluid loss were reported.The ams700 momentary squeeze pump was visually inspected.No leak was found.No connectors were returned.The pump was not functionally tested due to contamination.The allegation of connector disorder or fluid loss could not be confirmed.Based on the results of this investigation, no escalation is required.If further information is received at a later date, the product investigation will be reopened to address the additional information.
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Event Description
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It was reported that the patient experienced connector disorder with an inflatable penile prosthesis (ipp).The ipp pump, cylinder, and reservoir was explanted and a new ipp pump, cylinder, and reservoir was implanted.Additional information was reported that the connector did not stay straight in the body and being continuously rubbed against by the skin resulting in the connector being worn down an fluid loss with failure to cycle the device.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.
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Search Alerts/Recalls
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