Model Number 72404231 |
Device Problems
Collapse (1099); Fluid/Blood Leak (1250); Inflation Problem (1310); Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/01/2019 |
Event Type
Injury
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Event Description
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It was reported that the inflatable penile prosthesis (ipp) device is going to be revised on the first week in december because the "cylinders do not fill with liquid." additional information received states the pump bulb stayed flat and air was observed in the device.There was no hole observed in the device.It is believed there was fluid loss from the pump but the cause or source of the fluid loss was not known.It was observed that the pump was not pumping and was malfunctioning.The device issues began approximately 4 months prior to the surgery.Only the ipp cylinders were replaced.
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Manufacturer Narrative
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Device analysis: allegations related to inflation issues and pump malfunction were reported.The ams700 ipp cylinders and ms pump were visually inspected.One of the cylinders was separated in two pieces; a damage which was concluded to be sharp instrument damage consistent with explant damage.It was therefore considered a secondary failure.The other cylinder performed within specification.The pump was unable to be functionally tested due to contamination.Product analysis was unable to confirm the reported events.Visual inspection of the ams 700 ipp cylinders and momentary squeeze (ms) pump was unable to confirm the reported allegations of pump malfunction and inflation issues.The pump was unable to be functionally tested due to contamination and one of the cylinders could not be functionally tested.The other cylinder performed within specification.The product record review confirmed the reported events do not represent an unanticipated event nor did the device fail to meet applicable product specifications prior to shipment from boston scientific.An investigation conclusion code of cause not established was chosen as the most probable cause, because the cause of the reported events could not be identified through product investigation.The product analysis results and event report provided no objective evidence that would warrant further escalation.
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Event Description
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It was reported that the inflatable penile prosthesis (ipp) device is going to be revised on the first week in december because the cylinders do not fill with liquid additional information received states the pump bulb stayed flat and air was observed in the device.There was no hole observed in the device.It is believed there was fluid loss from the pump but the cause or source of the fluid loss was not known.It was observed that the pump was not pumping and was malfunctioning.The device issues began approximately 4 months prior to the surgery.Only the ipp cylinders were replaced.
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Search Alerts/Recalls
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