Model Number 72404310 |
Device Problem
Collapse (1099)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/27/2019 |
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 pump replacement due to a dimpled pump the patient had his inflatable penile prosthesis (ipp) removed and replaced.The ipp was explanted and a new device consisting of a 18cmx12mm cylinders, pump and reservoir were implanted.It was further reported that the patient pressed the pump, but the pump stayed flat.This occurred two weeks ahead of this surgery.The patient got well after this surgery.
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Manufacturer Narrative
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An allegation related to a pump collapse or "dimpled pump" was reported.The ams 700 momentary squeeze (ms) pump was visually inspected; no leaks were found.The pump was functionally tested and performed within specification.Product analysis was unable to confirm a device malfunction.Correction to g1, h2, h3, and h6: updated to include device analysis.Reservoir model- 72404161.Lot sn- (b)(6).Mfg date- 09/26/2018.Exp date- 09/25/2023.Gtin- (b)(4).
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Event Description
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It was reported that due to a pump replacement due to a dimpled pump the patient had his inflatable penile prosthesis (ipp) removed and replaced.The ipp was explanted and a new device consisting of a 18cm x 12mm cylinders, pump and reservoir were implanted.It was further reported that the patient pressed the pump, but the pump stayed flat.This occurred two weeks ahead of this surgery.The patient got well after this surgery.
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Search Alerts/Recalls
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