Model Number 72404252-10 |
Device Problems
Defective Device (2588); Malposition of Device (2616)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/02/2019 |
Event Type
malfunction
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Event Description
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It was reported that the patient underwent an inflatable penile prosthesis (ipp) original implant.For the procedure an lgx ipp was opened and prepped but upon implant, the surgeon noted the cylinders and pump were manufactured "backwards" as the deflate button faced anterior to the patient.The physician indicated that this has been a recurring issue and has occurred multiple times.A new lgx ipp was implanted to finish the procedure.The patient did not experience any further complications.
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Event Description
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It was reported that the patient underwent an inflatable penile prosthesis (ipp) original implant.For the procedure an lgx ipp was opened and prepped but upon implant, the surgeon noted the cylinders and pump were manufactured "backwards" as the deflate button faced anterior to the patient.The physician indicated that this has been a recurring issue and has occurred multiple times.A new lgx ipp was implanted to finish the procedure.The patient did not experience any further complications.Additional information was received in which it was stated that the physician suspected the device was placed incorrectly in the packaging causing the device to "set" in a specific orientation.When the device was attempted to be switched into another orientation it was unable to be completed and would revert back into the original orientation.No more information available at the moment.Should additional information become available, it will be provided.
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Manufacturer Narrative
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Ncep-00114946 was opened to further investigate and document the investigation for the ams 700 packaging requirements.Product investigation completed.Product analysis did not confirm the reported events.Visual and functional testing of the cylinders and pump concluded the components performed within specification.As confirmed by the manufacturing and operations quality engineer, the inflatable penile prosthesis (ipp) does not have a specified orientation, resulting in the device unable to be manufactured backwards.The allegation could not be confirmed nor replicated.Based on the results of this investigation, no escalation is required.
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Event Description
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It was reported that the patient underwent an inflatable penile prosthesis (ipp) original implant.For the procedure an lgx ipp was opened and prepped but upon implant, the surgeon noted the cylinders and pump were manufactured "backwards" as the deflate button faced anterior to the patient.The physician indicated that this has been a recurring issue and has occurred multiple times.A new lgx ipp was implanted to finish the procedure.The patient did not experience any further complications.
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Manufacturer Narrative
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Product investigation completed.Product analysis did not confirm the reported events.Visual and functional testing of the cylinders and pump concluded the components performed within specification.As confirmed by the manufacturing and operations quality engineer, the inflatable penile prosthesis (ipp) does not have a specified orientation, resulting in the device unable to be manufactured backwards.The allegation could not be confirmed nor replicated.Based on the results of this investigation, no escalation is required.
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Manufacturer Narrative
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B5, d6, d7, h2, h6, h10 updated.H2, h3, h6, h10 updated.Product investigation completed.Product analysis did not confirm the reported events.Visual and functional testing of the cylinders and pump concluded the components performed within specification.As confirmed by the manufacturing and operations quality engineer, the inflatable penile prosthesis (ipp) does not have a specified orientation, resulting in the device unable to be manufactured backwards.The allegation could not be confirmed nor replicated.Based on the results of this investigation, no escalation is required.
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Event Description
|
It was reported that the patient underwent an inflatable penile prosthesis (ipp) original implant.For the procedure an lgx ipp was opened and prepped but upon implant, the surgeon noted the cylinders and pump were manufactured "backwards" as the deflate button faced anterior to the patient.The physician indicated that this has been a recurring issue and has occurred multiple times.A new lgx ipp was implanted to finish the procedure.The patient did not experience any further complications.Additional information was received in which it was stated that the physician suspected the device was placed incorrectly in the packaging causing the device to "set" in a specific orientation.When the device was attempted to be switched into another orientation it was unable to be completed and would revert back into the original orientation.No more information available at the moment.Should additional information become available, it will be provided.
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Search Alerts/Recalls
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