It was reported that due to a dimpled pump the patient had his inflatable penile prosthesis (ipp) pump explanted.It was explained that the patient was seen by his physician and testing showed that when the pump was pressed it dimpled.The physician and nurses tried several times following known procedures in the hospital, but the device would not work as expected.The directions for using the pump was re-educated to the patient, and it was tested several times after implant to assure a working device.The patient got better after this operation.
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It was reported that due to a dimpled pump the patient had his inflatable penile prosthesis (ipp) pump explanted.It was explained that the patient was seen by his physician and testing showed that when the pump was pressed it dimpled.The physician and nurses tried several times following known procedures in the hospital, but the device would not work as expected.The patient was re-implanted with a different pump.The directions for using the pump was re-educated to the patient, and it was tested several times after implant to assure a working device.The patient got better after this operation.
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Changes made to this report.Describe event or problem device analysis, evaluation method codes, evaluation results and conclusion.Upon receipt at our post market quality assurance laboratory, the ams 700 momentary squeeze (ms) pump was visually inspected, and no leaks were found.The spring inside the pump observed to be non-concentric and the implant instructions stated that the coils of the poppet spring should not be crossed or misaligned.It was unknown when the misaligned poppet spring had occurred.The pump was functionally tested and did not pass the inflation test and activation test.He device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.Product analysis confirmed the reported allegations pump collapse.
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