Model Number 72404310 |
Device Problems
Mechanical Problem (1384); Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient went to the hospital because this inflatable penile prosthesis (ipp) was not working properly.Two weeks later, a revision surgery was performed, during which a crack in the connecting tube of the cylinder was identified.The pump was removed and replaced.There were no patient complications.
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Event Description
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It was reported that the patient went to the hospital because this inflatable penile prosthesis (ipp) was not working properly.Two weeks later, a revision surgery was performed, during which a crack in the connecting tube of the cylinder was identified.The pump was removed and replaced.There were no patient complications.
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Manufacturer Narrative
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Upon receipt at our quality assurance laboratory, the returned component underwent a thorough analysis.The pump was visually and microscopically inspected and tested for leaks.During visual examination it was noted that the tubing was cut down to the pump block; therefore, it was not returned for analysis.Microscopic evaluation revelated bodily fluid contamination within the pump; due to that finding, the component was not functionally tested.No leaks were identified in the pump.Based on the information available and analysis results, the reported clinical observation of the device not working properly due to a crack in the connecting tube could not be confirmed.
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Search Alerts/Recalls
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