Model Number 72404310 |
Device Problems
Collapse (1099); Deflation Problem (1149); Inflation Problem (1310)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/13/2019 |
Event Type
Injury
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Manufacturer Narrative
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Additional product component: model number/catalog number 72404161 and 72404292, serial number: null and nul,l batch/lot number 881191014 and 880766003, model/catalog description reservoir 65ml pc and snap fit rt.
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Event Description
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It was reported that the patient underwent a revision surgery due to dimpled pump with an inflatable penile prosthesis (ipp).The ipp cylinder, pump, and reservoir was explanted and a new ipp cylinder, pump, and reservoir was implanted.Additional information was reported that the patient presented to the physician that when the pump was pressed it would not inflate and remain collapsed, occurring two weeks prior to revision surgery.The patient recovered after the revision procedure.
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Event Description
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It was reported that the patient underwent a revision surgery due to dimpled pump with an inflatable penile prosthesis (ipp).The ipp cylinder, pump, and reservoir was explanted and a new ipp cylinder, pump, and reservoir was implanted.Additional information was reported that the patient presented to the physician that when the pump was pressed it would not inflate and remain collapsed, occurring two weeks prior to revision surgery.The patient recovered after the revision procedure.
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Manufacturer Narrative
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Cylinder analysis: product analysis concluded device malfunction were the most probably cause of the reported inflation issue.Fluid leaks due to input tube wear and fatigue were identified in both cylinders.These leaks would directly affect the functionality of the device and result in an inflation issue.Based on this investigation, the investigation conclusion code of cause traced to component failure was chosen because the reported events could be traced to a component failure through product investigation.Based on the results of this investigation, no escalation is required.
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Search Alerts/Recalls
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