Model Number 72404310 |
Device Problems
Collapse (1099); Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/02/2020 |
Event Type
Injury
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Manufacturer Narrative
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Device not returned for evaluation.
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Event Description
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It was reported that due to a right connector disorder the patient had his inflatable penile prosthesis (ipp) pump removed and replaced.It was also included that there was a "pump connection tube failure." additional information was received that the pump bulb stayed flat when pressing the bulb.This occurred two weeks ahead of surgery and the patient got well after this surgery.
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Event Description
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It was reported that due to a right connector disorder the patient had his inflatable penile prosthesis (ipp) pump removed and replaced.It was also included that there was a "pump connection tube failure." additional information was received that the pump bulb stayed flat when pressing the bulb.This occurred two weeks ahead of surgery and the patient got well after this surgery.
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Manufacturer Narrative
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A pump connection issue was reported along with pump collapse.The ams 700 momentary squeeze (ms) pump was visually inspected; no tubing nor connectors were present as the pump krt was cut down to the pump block.No leaks were identified.Pump contamination was present resulting in an inability to functionally test the pump.Product analysis was therefore unable to confirm the reported allegations.
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Search Alerts/Recalls
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