BOSTON SCIENTIFIC CORPORATION REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994); Sexual Dysfunction (4510); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/08/2024 |
Event Type
Injury
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Manufacturer Narrative
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B3.Date of event the exact date of the event is unknown, estimated.The bsc aware date was used.
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Event Description
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It was reported by a patient, that approximately two and a half years ago, he received a water vapor therapy procedure to treat his benign prostatic hyperplasia (bph), he states that the procedure was painful.Additionally, after receiving the approval to have intercourse, the patient is unable ejaculation or experience an orgasm.Also, the patient has experienced inflammation in his right testicle.To date, the patient continues to experience the symptoms mentioned above and has stated that this has affected his life.The patient indicates that he did not return to the doctor who performed the procedure since he indicates he was not given any guidance.He is being treated by another doctor, who informed him that he cannot help with his symptoms.No further information is available.
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Manufacturer Narrative
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Correction to field h6.Patient code and impact code updated.B3.Date of event the exact date of the event is unknown, estimated.The bsc aware date was used.
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Event Description
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It was reported by a patient, that approximately two and a half years ago, he received a water vapor therapy procedure to treat his benign prostatic hyperplasia (bph), he states that the procedure was painful.Additionally, after receiving the approval to have intercourse, the patient is unable ejaculation or experience an orgasm.Also, the patient has experienced inflammation in his right testicle.To date, the patient continues to experience the symptoms mentioned above and has stated that this has affected his life.The patient indicates that he did not return to the doctor who performed the procedure since he indicates he was not given any guidance.He is being treated by another doctor, who informed him that he cannot help with his symptoms.No further information is available.
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Manufacturer Narrative
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B3.Date of event the exact date of the event is unknown, estimated.The bsc aware date was used.Boston scientific concludes that the reported allegations in this complaint have not been confirmed, as the product was not returned for analysis.Without a returned device, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
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Event Description
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It was reported by a patient, that approximately two and a half years ago, he received a water vapor therapy procedure to treat his benign prostatic hyperplasia (bph), he states that the procedure was painful.Additionally, after receiving the approval to have intercourse, the patient is unable ejaculation or experience an orgasm.Also, the patient has experienced inflammation in his right testicle.To date, the patient continues to experience the symptoms mentioned above and has stated that this has affected his life.The patient indicates that he did not return to the doctor who performed the procedure since he indicates he was not given any guidance.He is being treated by another doctor, who informed him that he cannot help with his symptoms.No further information is available.
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Search Alerts/Recalls
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