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
Micturition Urgency (1871); Muscle Spasm(s) (1966); Pain (1994); Dysuria (2684)
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Event Date 02/21/2019 |
Event Type
Injury
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Event Description
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During procedure, the patient was administered iv sedation, pain medication, and general anesthesia.A total of 10 treatments were administered.There were no device observations or adverse events during the procedure.Post procedure, the patient was discharged with an indwelling catheter.It was reported that 7 days post procedure, the patient catheter was removed, and the patient reported to be experiencing urinary hesitancy and suprapubic pain.The patient was given medication (unknown type and dose) only for the urinary hesitancy resolving the symptom.The symptom was assessed as being related to the procedure; however, unlikely related to the device.The assessment of the device relationship for the suprapubic pain patient symptom was assessed as unlikely related; however, as probable related to the procedure.At 62 days post the procedure the patient was reported to be experiencing bladder spasms; however, no medical action was taken.The investigator assessment of the device relationship for the bladder spasm was assessed as possible related to the procedure; but unlikely related to the device.No further information is available.
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Manufacturer Narrative
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Describe event or problem: updated to reflect resolution of the patient symptoms of bladder spasm and suprapubic pain.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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During procedure, the patient was administered iv sedation, pain medication, and general anesthesia.A total of 10 treatments were administered.There were no device observations or adverse events during the procedure.Post procedure, the patient was discharged with an indwelling catheter.It was reported that 7 days post procedure, the patient catheter was removed, and the patient was reported to be experiencing urinary hesitancy and suprapubic pain.At 62 days the patient was reported to have experienced a single episode of bladder spasm.The patient was given alfuzosin (dose unknown) for the urinary hesitancy resolving 28 days post onset symptom and administered 200mg celebrex for the suprapubic pain resolving 84 days post onset symptom.The bladder spasm was reported to have resolved 19 days post onset symptom without treatment.The facility investigator assessment of the patient symptom of urinary hesitancy was assessed as definitely procedure related, the suprapubic pain symptom as probable procedure related, and the bladder spasm as possible procedure related.The device relationship to the symptoms of urinary hesitancy, suprapubic pain and bladder spasm were assessed as unlikely related to device.The clinical end point committee (cec) adjudicated the urinary hesitancy as definite treatment related, and the suprapubic pain as probable treatment related.The cec adjudication for the urinary hesitancy was assessed as unlikely device related and for the suprapubic pain was adjudicated to not device related.
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Manufacturer Narrative
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Event description was updated with medication administered for the urinary hesitancy and adjudication update for the reported urinary hesitancy as being definite related to treatment.
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Event Description
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During procedure, the patient was administered iv sedation, pain medication, and general anesthesia.A total of 10 treatments were administered.There were no device observations or adverse events during the procedure.Post procedure, the patient was discharged with an indwelling catheter.It was reported that 7 days post procedure, the patient catheter was removed, and the patient reported to be experiencing urinary hesitancy and suprapubic pain.The patient was administered afuzosin hci (unknown dose) only for the urinary hesitancy resolving the symptom.The urinary hesitancy symptom was assessed as definite being related to the treatment; however, unlikely related to the device.The assessment of the device relationship for the suprapubic pain patient symptom was assessed as unlikely related; however, as probable related to the procedure.At 62 days post the procedure the patient was reported to be experiencing bladder spasms; however, no medical action was taken.The investigator assessment of the device relationship for the bladder spasm was assessed as possible related to the procedure; but unlikely related to the device.No further information is available.
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Manufacturer Narrative
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Describe event or problem: updated to reflect resolution of the patient symptoms of bladder spasm and suprapubic pain.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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During procedure, the patient was administered iv sedation, pain medication, and general anesthesia.A total of 10 treatments were administered.There were no device observations or adverse events during the procedure.Post procedure, the patient was discharged with an indwelling catheter.It was reported that 7 days post procedure, the patient catheter was removed, and the patient reported to be experiencing urinary hesitancy and suprapubic pain.The patient was administered afuzosin hci (unknown dose) only for the urinary hesitancy resolving the symptom.The suprapubic pain resolved 84 days post onset symptom.The urinary hesitancy symptom was assessed as definite being related to the treatment; however, unlikely related to the device.The assessment of the device relationship for the suprapubic pain patient symptom was assessed as unlikely related; however, as probable related to the procedure.At 62 days post the procedure the patient was reported to be experiencing bladder spasms; however, no medical action was taken.The bladder spasm symptom resolved 29 days post onset symptom.The investigator assessment of the device relationship for the bladder spasm was assessed as possible related to the procedure; but unlikely related to the device.No further information is available.
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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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During procedure, the patient was administered iv sedation, pain medication, and general anesthesia.A total of 10 treatments were administered.There were no device observations or adverse events during the procedure.Post procedure, the patient was discharged with an indwelling catheter.It was reported that 7 days post procedure, the patient catheter was removed, and the patient reported to be experiencing urinary hesitancy and suprapubic pain.The patient was administered afuzosin hci (unknown dose) only for the urinary hesitancy resolving the symptom.The urinary hesitancy symptom was assessed as definite being related to the treatment; however, unlikely related to the device.The assessment of the device relationship for the suprapubic pain patient symptom was assessed as unlikely related; however, as probable related to the procedure.At 62 days post the procedure the patient was reported to be experiencing bladder spasms; however, no medical action was taken.The investigator assessment of the device relationship for the bladder spasm was assessed as possible related to the procedure; but unlikely related to the device.No further information is available.
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