BOSTON SCIENTIFIC CORPORATION REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Model Number D2201 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Date 04/26/2019 |
Event Type
Injury
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Manufacturer Narrative
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Dr.(b)(6).
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Event Description
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The patient underwent a convective radiofrequency water vapor thermal therapy procedure of the prostate.During procedure the patient was administered a prostate blocker for pain and a few minutes later the procedure began.It was reported by the patient that the procedure was extremely painful.The physician continued with the procedure, and it is believed that nine injections were given.The patient remained with a leg bag catheter for ten days post procedure and with little instructions.The catheter was removed, and the patient thought things would improve but did not.The patient returned to the physician and was told that procedure results takes time.The patient returned to the physician four months post procedure, and the physician stated that it was not doing badly after 4 weeks.The patient corrected the physician by clarifying that it has been four months since the procedure.The physician performed a cystoscopy and stated that the procedure did not work.The physician recommended the patient to try photovaporization (pvp) laser treatment.The patient did not schedule with the physician and had nothing further done.The patients issues have slightly improved but is getting worse.
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Manufacturer Narrative
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(b)(6).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, pain is 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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The patient underwent a convective radiofrequency water vapor thermal therapy procedure of the prostate.During procedure the patient was administered a prostate blocker for pain and a few minutes later the procedure began.It was reported by the patient that the procedure was extremely painful.The physician continued with the procedure, and it is believed that nine injections were given.The patient remained with a leg bag catheter for ten days post procedure and with little instructions.The catheter was removed, and the patient thought things would improve but did not.The patient returned to the physician and was told that procedure results takes time.The patient returned to the physician four months post procedure, and the physician stated that it was not doing badly after 4 weeks.The patient corrected the physician by clarifying that it has been four months since the procedure.The physician performed a cystoscopy and stated that the procedure did not work.The physician recommended the patient to try photovaporization (pvp) laser treatment.The patient did not schedule with the physician and had nothing further done.The patients issues have slightly improved but is getting worse.
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Search Alerts/Recalls
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