Model Number 72404310 |
Device Problems
Collapse (1099); Inflation Problem (1310)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 01/31/2020 |
Event Type
Injury
|
Event Description
|
It was reported that due to a pump replacement due to a dimpled pump the patient had an inflatable penile prothesis (ipp) pump removed and replaced.It was further reported that the pump stayed flat when pressing the bulb and due to this the patient was unable to inflate the device.The patient got well after this surgery.
|
|
Manufacturer Narrative
|
Device analysis: the returned device was analyzed and the reported event was confirmed.Based on a review of all available information, the cause of the reported event could not be determined.Analysis confirmed the reported complaint pump malfunction following the analysis of the activation test.
|
|
Event Description
|
It was reported that the patient underwent a revision procedure due to the pump staying flat when pressing the bulb and unable to inflate the device with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.The patient recovered following the procedure.
|
|
Search Alerts/Recalls
|