Model Number 72404310 |
Device Problems
Collapse (1099); Fluid/Blood Leak (1250); Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/14/2019 |
Event Type
Injury
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Manufacturer Narrative
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Additional product component: model number/catalog number 72404161; batch/lot number: 100727009; model/catalog description: reservoir 65ml.
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Event Description
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It was reported that the patient experienced inflation issues and the pump remained flat after being pressed due to fluid loss with a connector crack with an inflatable penile prosthesis (ipp).The ipp cylinder, pump, and reservoir was explanted and a new ipp cylinder, pump, and reservoir was implanted.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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Event Description
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It was reported that the patient experienced inflation issues and the pump remained flat after being pressed due to fluid loss with a connector crack with an inflatable penile prosthesis (ipp).The ipp cylinder, pump, and reservoir was explanted and a new ipp cylinder, pump, and reservoir was implanted.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: pump was visually tested and leak tested, no defects detected.Functional test was conducted and pump was unable to inflate or deflate.Each functional test was performed three times.Based on a thorough review of the reported complaint, the most probable cause for this complaint was considered cause traced to component failure.This complaint investigation conclusion code is utilized for an expected or random component failure without any design or manufacturing issue.Based on the results of this investigation, no escalation is necessary.Additional product component: model number/catalog number, 72404161, serial number: null, batch/lot number 100727009, model/catalog description reservoir 65ml.
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Search Alerts/Recalls
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