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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); Patient Problem/Medical Problem (2688)
Event Date 03/14/2019
Event Type  Injury  
Event Description
It was reported that post convective radiofrequency water vapor thermal therapy procedure, the patient experienced a single episode of foley catheter blockage that was resolved by replacing the catheter in the er.At 21 days post the index procedure, the patient was reported to be experiencing urinary urgency.The investigator assessed the catheter blockage as related to the treatment and possible related to the device.The patient symptoms of urinary urgency was assessed as treatment and device related.Adjudication by the clinical endpoint committee (cec) assessed that the catheter blockage event was definite related to the treatment and unlikely related to the device.The patient symptom of urinary urgency was adjudicated as treatment related and possible related to the device.
 
Manufacturer Narrative
Event description updated to reflect resolution of the urinary urgency.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.
 
Event Description
It was reported that post convective radiofrequency water vapor thermal therapy procedure, the patient experienced a single episode of foley catheter blockage that was resolved by replacing the catheter in the er.At 21 days post the index procedure, the patient was reported to be experiencing urinary urgency.The urinary urgency was reported to have resolved 108 days post onset symptom.The investigator assessed the catheter blockage as related to the treatment and possible related to the device.The patient symptoms of urinary urgency was assessed as treatment and device related.Adjudication by the clinical endpoint committee (cec) assessed that the catheter blockage event was definite related to the treatment and unlikely related to the device.The patient symptom of urinary urgency was adjudicated as treatment related and possible related to the device.
 
Manufacturer Narrative
Event description updated to reflect resolution of the urinary urgency.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.
 
Event Description
The patient underwent the study procedure and administered iv sedation and pain medication.A total of 14 treatments were delivered.No adverse event or device observation were noted during the procedure.It was reported that post convective radiofrequency water vapor thermal therapy procedure, a single episode of foley catheter block occurred.The foley catheter event was resolved by replacing the catheter in the er and administering 250mg cefuroxime axetil and 2% lidocaine.The investigator assessed the catheter blockage as related to the treatment and unlikely to be delivery device related.The foley cathether blockage was assessed as possible related to the catheter (unknown manufacturer).At 21 days post the index procedure, the patient was reported to be experiencing a single episode of urinary urgency for which no action was taken.The urinary urgency resolved 3 months with 9 days post onset symptom without action taken.The patient symptom of urinary urgency was assed as definitely related to the procedure and device.The cec adjudicated the foley blockage catheter malfunction requiring treatment as treatment related and unlikely related to the delivery device.The ced adjudicated the urinary urgency event to be definite treatment related and possible 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 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.
 
Event Description
It was reported that post convective radiofrequency water vapor thermal therapy procedure, the patient experienced a single episode of foley catheter blockage that was resolved by replacing the catheter in the er.At 21 days post the index procedure, the patient was reported to be experiencing urinary urgency.The investigator assessed the catheter blockage as related to the treatment and possible related to the device.The patient symptoms of urinary urgency was assessed as treatment and device related.Adjudication by the clinical endpoint committee (cec) assessed that the catheter blockage event was definite related to the treatment and unlikely related to the device.The patient symptom of urinary urgency was adjudicated as treatment related and possible related to the device.
 
Event Description
The patient underwent the study procedure and administered iv sedation and pain medication.A total of 14 treatments were delivered.No adverse event or device observation were noted during the procedure.It was reported that post convective radiofrequency water vapor thermal therapy procedure, a single episode of foley catheter block occurred.The foley catheter event was resolved by replacing the catheter in the er and administering 250mg cefuroxime axetil and 2% lidocaine.The investigator assessed the catheter blockage as procedure related and not related to the delivery device.The foley cathether blockage was assessed as possible related to the catheter (unknown manufacturer).At 21 days post the index procedure, the patient was reported to be experiencing a single episode of urinary urgency for which no action was taken.The urinary urgency resolved 3 months with 9 days post onset symptom without action taken.The patient symptom of urinary urgency was assed as definitely related to the procedure and device.The cec adjudicated the foley blockage catheter malfunction requiring treatment as treatment related and unlikely related to the delivery device.The ced adjudicated the urinary urgency event to be definite treatment related and possible related to the device.
 
Manufacturer Narrative
B5 event description updated to reflect foley blockage device relationship to not related.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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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 Key8742446
MDR Text Key149481682
Report Number2937094-2019-60815
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,Followup
Report Date 10/12/2020
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 Expiration Date11/30/2019
Device Model NumberD2201
Device Catalogue NumberD2201
Device Lot Number2018110702
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/04/2019
Initial Date FDA Received06/27/2019
Supplement Dates Manufacturer Received07/09/2019
09/19/2019
10/29/2019
09/17/2020
Supplement Dates FDA Received07/25/2019
09/25/2019
11/11/2019
10/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age62 YR
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