Model Number 72403334 |
Device Problems
Collapse (1099); Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/15/2019 |
Event Type
Injury
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Manufacturer Narrative
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Additional product component: model number/catalog number: 72400152, serial number: null, batch/lot number 398781004, model/catalog description reservoir 65ml.
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Event Description
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It was reported that the patient experienced cylinder rupture resulting in fluid loss and the pump stayed collapsed with an inflatable penile prosthesis (ipp).The ipp cylinder and pump were explanted, the reservoir could not be explanted due to heavy encapsulation after duration of implant and a new ipp cylinder and pump were 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: malfunction was reported.The ams700 device was visually inspected and functionally tested.There was a leak in one cylinder due to fold wear this cylinder also and broken fabric threads.This cylinder also had a hole in the outer tube due to sharp instrument damage consistent with explant damage.The other cylinder had broken fabric threads and bulging when inflated.The pump was not functionally tested due to the cylinder failures.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 72400152, serial number: null, batch/lot number 398781004, model/catalog description reservoir 65ml.
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Event Description
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It was reported that the patient experienced cylinder rupture resulting in fluid loss and the pump stayed collapsed with an inflatable penile prosthesis (ipp).The ipp cylinder and pump were explanted, the reservoir could not be explanted due to heavy encapsulation after duration of implant and a new ipp cylinder and pump were 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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Search Alerts/Recalls
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