Model Number 72404155 |
Device Problems
Degraded (1153); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/21/2020 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a revision procedure due to the reservoir was full of clots and both cylinders were damaged with an inflatable penile prosthesis (ipp).The ipp cylinder, pump, and reservoir was explanted and a new ipp cylinder, pump, and reservoir was implanted.
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Manufacturer Narrative
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Reservoir analysis: an allegation of device malfunction and foreign material was made.The ams700 ipp reservoir were visually inspected and functionally tested.The reservoir performed within specification.Product analysis could not confirm the reported events.Cylinder analysis: product analysis was unable to confirm the reported allegation related to cylinders damaged and degraded as sharp instrument damage was identified.The ams700 ipp cylinders were visually inspected and functionally tested.Both cylinders had leak in cylinder body that was result of sharp instrument damage which occurred during the explant; holes were present.These damages were consistent with explant damage and were considered a secondary failure.Both cylinders had wear at fold in cylinder body.
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Event Description
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It was reported that the patient underwent a revision procedure due to the reservoir was full of clots and both cylinders were damaged with an inflatable penile prosthesis (ipp).The ipp cylinder, pump, and reservoir was explanted and a new ipp cylinder, pump, and reservoir was implanted.
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Search Alerts/Recalls
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