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
Hematuria (2558); Dysuria (2684)
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Event Date 08/10/2019 |
Event Type
Injury
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Event Description
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The patient was given iv sedation, pain medication, and general anesthesia.During procedure, a total of 13 treatment were delivered.No device observations or adverse events occurred during the procedure.The patient was discharged the same day post procedure with an indwelling catheter.It was reported that 9 days post the index procedure the patient was reported to be experiencing dysuria (pain with urination) and gross hematuria in urine after increased physical activity.There was no action take for the gross hematuria and reported to have resolved 4 days post onset symptom.The patient symptom of dysuria was reported have resolved 19 days post onset symptom.The patient indwelling catheter was removed 54 days post the index procedure.The patient symptoms were assessed as probable related to the procedure and unlikely related to the device.
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Event Description
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The patient was given iv sedation, pain medication, and general anesthesia.During procedure, a total of 13 treatment were delivered.No device observations or adverse events occurred during the procedure.The patient was discharged the same day post procedure with an indwelling catheter.It was reported that 9 days post the index procedure the patient was reported to be experiencing dysuria (pain with urination) and gross hematuria in urine after increased physical activity.There was no action take for the gross hematuria and reported to have resolved 4 days post onset symptom.The patient symptom of dysuria was reported have resolved 19 days post onset symptom.The patient indwelling catheter was removed 54 days post the index procedure.The patient symptoms were assessed as probable related to the procedure and unlikely related to the device.
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Manufacturer Narrative
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The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.The device is not available for analysis and no device failure was reported by the study facility.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, an evaluation conclusion code of known inherent risk of the device was assigned to this investigation.
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Search Alerts/Recalls
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