Model Number 72404231 |
Device Problems
Collapse (1099); Fluid/Blood Leak (1250); Inflation Problem (1310)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/28/2019 |
Event Type
Injury
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Manufacturer Narrative
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Medical device: model number/catalog number 720185-01, serial number (b)(4), batch/lot number 151513011, gtin (b)(4), description reservoir flat iz 100 ml, expiration date 09/29/2018, medical device: manufacturer date 10/19/2016.
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Event Description
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It was reported that the patient had the inflatable penile prosthesis removed due to the right cylinder failing to inflate properly upon activation.When activated, the pump also appeared misshapen within the patients scrotum.The reservoir was found during the procedure to contain significantly less fluid than it had been filled with.A new inflatable penile prosthesis consisting of cylinders, pump, and reservoir were implanted.Additional information received indicated that the leak was unknown at time of surgery, all that was found was that there was only a small volume of saline left in the system and that the pump was depressed when the device was activated.
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Event Description
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It was reported that the patient had the inflatable penile prosthesis removed due to the right cylinder failing to inflate properly upon activation.When activated, the pump also appeared misshapen within the patients scrotum.The reservoir was found during the procedure to contain significantly less fluid than it had been filled with.A new inflatable penile prosthesis consisting of cylinders, pump, and reservoir were implanted.Additional information received indicated that the leak was unknown at time of surgery, all that was found was that there was only a small volume of saline left in the system and that the pump was depressed when the device was activated.
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Manufacturer Narrative
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Device analysis: returned product consisted of cx preconnect ms 15cm ps iz.The device passed functional testing and did not have any damage.The reported device failure was not confirmed.Based on a lack of damage on the returned device and the successful functional test, the most probable cause for this complaint was considered no problem detected.This complaint investigation conclusion code is utilized when the device complaint or problem cannot be confirmed.Based on the results of this investigation, no escalation is necessary.D4 model number/catalog number 720185-01.Serial number (b)(6).Batch/lot number 151513011.Gtin 878953005669.Description reservoir flat iz 100 ml.Expiration date 09/29/2018.H4 manufacturer date 10/19/2016.
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Search Alerts/Recalls
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