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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDPLAST MEDICAL, INC. REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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MEDPLAST MEDICAL, INC. REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number D2201
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Micturition Urgency (1871); Incontinence (1928); Complaint, Ill-Defined (2331); Dysuria (2684); Patient Problem/Medical Problem (2688)
Event Date 12/17/2018
Event Type  Injury  
Event Description
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.
 
Manufacturer Narrative
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.
 
Event Description
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.
 
Manufacturer Narrative
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.
 
Event Description
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.
 
Event Description
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.
 
Manufacturer Narrative
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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Brand Name
REZUM
Type of Device
UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
MEDPLAST MEDICAL, INC.
5079 33rd street se
grand rapids MI 49512
MDR Report Key8742470
MDR Text Key149487012
Report Number2937094-2019-60812
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
PMA/PMN Number
K180237
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study,user facility
Type of Report Initial,Followup,Followup,Followup
Report Date 12/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberD2201
Device Catalogue NumberD2201
Device Lot Number2018020319
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/04/2019
Initial Date FDA Received06/27/2019
Supplement Dates Manufacturer Received06/27/2019
10/29/2019
12/18/2019
Supplement Dates FDA Received07/19/2019
11/08/2019
12/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age75 YR
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