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); Incontinence (1928); Complaint, Ill-Defined (2331); Dysuria (2684); Patient Problem/Medical Problem (2688)
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Event Date 12/17/2018 |
Event Type
Injury
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Event Description
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It was reported that 4 days post convective radiofrequency water vapor thermal therapy treatment, the patient experienced a single episode of foley catheter block.The catheter was irrigated in the er resolving the event.The investigator assessed the patient event as treatment related and unlikely related to the device.Adjudication by the clinical endpoint committee (cec) assessed that the event was definite related to the treatment and unlikely related to the device.
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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(s) and controls for complaints related to the clinical event were identified.Based on review of the information available an assignable cause of known inherent risk of device was assigned to this investigation.
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Event Description
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It was reported that 4 days post convective radiofrequency water vapor thermal therapy treatment, the patient experienced a single episode of foley catheter block.The catheter was irrigated in the er resolving the event.At 8 days post the index procedure, the patient was reported to be experiencing post void dribble, urgency incontinence and dysuria.Unspecified treatment was administered only for the post void dribble.The symptom of dysuria was reported to have resolved.The investigator assessment of the symptoms of post void dribble, and urgency incontinence were assessed as treatment related but unlikely related to the device.The symptom of dysuria was assessed as definite related to the treatment and possible related to the device.The clinical endpoint committee adjudicated the single episode of foley catheter block as definite related to the treatment and unlikely related to the device.
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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(s) and controls for complaints related to the clinical event were identified.Based on review of the information available an assignable cause of known inherent risk of device was assigned to this investigation.
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Event Description
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The subject underwent the study procedure and administered iv sedation, pain medication and general anesthesia.A total of 13 treatment were delivered.There were no adverse events or device observation during procedure.It was reported that 4 days post convective radiofrequency water vapor thermal therapy procedure, the patient experienced a single episode of foley catheter block.The catheter was irrigated in the er resolving the event.At 8 days post the index procedure, the patient was reported to be experiencing urgency incontinence, post void dribble and dysuria.The patient was administered myrbetriq (unknown dose) for the urgency incontinence symptom, and is wearing pad for the post void dribble, both symptoms are still ongoing.The patient symptoms of dysuria resolved 4 months and 11 days post onset symptom.The facility investigator assessed the patient foley catheter block definitely related to the procedure and unlikely related to the delivery device.The symptom of post void dribble, and urgency incontinence were assessed as treatment related but unlikely related to the device.The symptom of dysuria was assessed as definite related to the treatment and possible related to the device.The clinical end point committee adjudicated the foley catheter block, urgency incontinence, post void dribble and dysuria to definite related to the treatment and unlikely related to the device.
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Event Description
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The subject underwent the study procedure and administered iv sedation, pain medication and general anesthesia.A total of 13 treatment were delivered.There were no adverse events or device observation during procedure.It was reported that 4 days post convective radiofrequency water vapor thermal therapy procedure, the patient experienced a single episode of foley catheter block.The catheter was irrigated in the er resolving the event.At 8 days post the index procedure, the patient was reported to be experiencing urgency incontinence, post void dribble and dysuria.The patient was administered myrbetriq (unknown dose) for the urgency incontinence symptom, and is wearing pad for the post void dribble.The patient symptom of dysuria resolved 4 months and 11 days post onset symptom and the symptom of post void dribble resolved approximately 8 months post onset symptom.The facility investigator assessed the patient foley catheter block definitely related to the procedure and unlikely related to the delivery device.The symptom of post void dribble, and urgency incontinence were assessed as treatment related but unlikely related to the device.The symptom of dysuria was assessed as definite related to the treatment and possible related to the device.The clinical end point committee adjudicated the foley catheter block, urgency incontinence, post void dribble and dysuria to definite related to the treatment and unlikely related to the device.
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Manufacturer Narrative
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Event description: updated to reflect resolution of post void dribble.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(s) and controls for complaints related to the clinical event were identified.Based on review of the information available an assignable cause of known inherent risk of device was assigned to this investigation.
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Search Alerts/Recalls
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