MEDPLAST MEDICAL, INC. 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 Problems
Urinary Retention (2119); Urinary Tract Infection (2120); Discomfort (2330); Dysuria (2684)
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Event Date 09/13/2018 |
Event Type
Injury
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Manufacturer Narrative
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The device is not available for analysis.A review of the device ifu and operators manual was completed and did not reveal any evidence of device misuse, off-label use, or failure to follow instructions.The potential cause and controls for complaints related to clinical events were identified.Based on the information currently available, the patient symptoms are known risk associated with this type of procedure.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 same day post convective radiofrequency water vapor thermal therapy procedure, the patient experienced urinary discomfort for which medication (unknown type and dose) was administered.Eight days post index procedure, the patient was reported to have experienced dysuria and urinary tract infection (uti).The patient was treated (unknown treatment type) for the dysuria symptom and was administered medication (unknown type and dose) for the uti.The symptom of urinary discomfort was reported to have resolved 5 days post onset symptom, the dysuria resolved 27 days post onset symptom, and the uti resolved 43 days post onset symptom.The patient symptom of urinary discomfort was assessed to be definite treatment related and possible device related.The patient symptom of dysuria was assessed as probable related to the treatment and unlikely related to the device.The patient symptom of uti was assessed as probable treatment related and probable related to the device.
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Manufacturer Narrative
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Describe event or problem: updated to reflect additional patient symptom of urinary retention.The device is not available for analysis.A review of the device ifu and operators manual was completed and did not reveal any evidence of device misuse, off-label use, or failure to follow instructions.The potential cause and controls for complaints related to clinical events were identified.Based on the information currently available, the patient symptoms are known risk associated with this type of procedure.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 same day post convective radiofrequency water vapor thermal therapy procedure, the patient experienced urinary discomfort for which medication (unknown type and dose) was administered.Eight days post index procedure, the patient was reported to have experienced dysuria and urinary tract infection (uti).The patient was treated (unknown treatment type) for the dysuria symptom and was administered medication (unknown type and dose) for the uti.At 11 days post procedure, the patient was reported to be experiencing acute urinary retention for which tamsulosin (unknown dose) and catheterization were administer.The symptom of urinary discomfort was reported to have resolved 5 days post onset symptom, the dysuria resolved 27 days post onset symptom, uti resolved 43 days post onset symptom and the urinary retention was reported to have resolved 31 days post onset symptom.The patient symptom of urinary discomfort was assessed to be definite treatment related and possible device related.The patient symptom of dysuria was assessed as probable related to the treatment and unlikely related to the device.The patient symptom of uti was assessed as probable treatment related and probable related to the device.The urinary retention was assessed as definitely related to the procedure and not related to the device.The clinical end point committee assessed the event as probable treatment related and possible related to the device.
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