Model Number 720133-01 |
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 12/20/2023 |
Event Type
Injury
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Manufacturer Narrative
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The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.
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Event Description
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It was reported that this artificial urinary sphincter (aus) was not working properly.Two weeks later a revision surgery was performed, upon examination a hole in the cuff was found.The device was explanted and replaced.No patient complications were reported.
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Manufacturer Narrative
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Upon receipt at our quality assurance laboratory, this artificial urinary sphincter (aus) underwent a thorough analysis.The cuff was visually inspected and underwent leak testing.A pinhole was found in the cuff shell consistent with wear at a fold which led to fluid leakage.No visual damages nor abnormalities were found neither in the pump nor the balloon, and both components passed leak testing.Based on the information available and analysis results, the cuff pinhole could have caused or contributed to the reported clinical observation of mechanical issue; therefore, a conclusion code of cause traced to component failure was assigned to this investigation.
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Event Description
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It was reported that this artificial urinary sphincter (aus) was not working properly.Two weeks later a revision surgery was performed, upon examination a hole in the cuff was found.The device was explanted and replaced.No patient complications were reported.
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Search Alerts/Recalls
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