Model Number D2201 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994); Complaint, Ill-Defined (2331)
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Event Date 01/31/2020 |
Event Type
Injury
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Event Description
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It was reported that this patient underwent convective radiofrequency water vapor thermal therapy procedure of the prostate on (b)(6) 2020 using the delivery device.Prior to the procedure the patients prostate specific antigen (psa) results and palpation of the prostate were not considered a concern.In (b)(6) 2020, the patient experienced heavy bleeding following sexual activity that lasted for 11 days as well as pain in the prostate area.In (b)(6) 2020, there was prostate inflammation.The patient is taking the prescribed medication but experienced tissue detachment at the end of (b)(6) 2020.The patients urinary stream is also weak and split.The urologist suspects there is residual tissue present and is considering performing a peeling procedure at a later date.No additional adverse patient effects were reported; however, the patients urinary stream is becoming weaker and the patient is concerned about prostate cancer.At this time, no further information on this event has been reported.
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Manufacturer Narrative
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The device is not available for analysis.A review of the ifu and operators manual was completed and did not reveal any evidence of device misuse, off-label use, or failure to follow instructions.Based on review of the information available, hemorrhage, pain and inflammation are known risk associated with the use of the device and is noted as such in the instruction for use (ifu).An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.
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Event Description
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It was reported that the patient underwent convective radiofrequency water vapor thermal therapy procedure of the prostate on (b)(6) 2020, using the delivery device.Prior to the procedure the patient prostate specific antigen (psa) results and palpation of the prostate were not considered a concern.In (b)(6) 2020, the patient experienced heavy bleeding following sexual activity that lasted for 11 days as well as pain in the prostate area.In (b)(6) 2020, there was prostate inflammation.The patient is taking the prescribed medication but experienced tissue detachment at the end of (b)(6) 2020.The patient urinary stream is also weak and split.The urologist suspects there is residual tissue present and is considering performing a peeling procedure at a later date.No additional adverse patient effects were reported; however, the patient urinary stream is becoming weaker and the patient is concerned about prostate cancer.At this time, no further information on this event has been reported.
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Event Description
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It was reported that the patient underwent convective radiofrequency water vapor thermal therapy procedure of the prostate on (b)(6) 2020 using the delivery device.Prior to the procedure the patient's prostate specific antigen (psa) results and palpation of the prostate were not considered a concern.In (b)(6) 2020 the patient experienced heavy bleeding following sexual activity that lasted for 11 days as well as pain in the prostate area.In (b)(6) 2020 there was prostate inflammation.The patient is taking the prescribed medication but experienced tissue detachment at the end of (b)(6) 2020.The patients urinary stream is also weak and split.The urologist suspects there is residual tissue present and is considering performing a peeling procedure at a later date.No additional adverse patient effects were reported; however, the patient's urinary stream is becoming weaker and the patient is concerned about prostate cancer.At this time, no further information on this event has been reported.
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Manufacturer Narrative
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B1 adverse event/product problem field corrected.
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Search Alerts/Recalls
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