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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 Hemorrhage/Bleeding (1888); Incontinence (1928); Urinary Retention (2119); Hematuria (2558); Patient Problem/Medical Problem (2688)
Event Date 09/03/2019
Event Type  Injury  
Event Description
The patient underwent convective radiofrequency water vapor thermal therapy of the prostate.During procedure the patient was given iv sedation, pain medication and general anesthesia.A total of 12 treatments were delivered.No device observations or adverse events occurred during the procedure.The patient was discharged with an indwelling catheter which was removed 8 days post the index procedure.It was reported that on the 8th day post procedure, the patient was reported to be experiencing worsening hesitancy, worsening urinary incontinence, worsening dribbling urine (weak stream), incomplete emptying of bladder and hematuria.At 16 days post the index procedure, the patient was also reported to be experiencing hematospermia.The patient symptom of hematospermia resolved 20 days post onset symptom, and the hematuria resolved 28 days post onset symptoms, both, without medical treatment.The remaining patient symptoms are still ongoing and no treatment has been administered.The facility investigator assessed the patient symptoms to be possibly related to the procedure and not related to the device.
 
Manufacturer Narrative
The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.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 an evaluation conclusion code of known inherent risk of the device was assigned to this investigation.
 
Event Description
The patient underwent convective radiofrequency water vapor thermal therapy of the prostate.During procedure the patient was given iv sedation, pain medication and general anesthesia.A total of 12 treatments were delivered.No device observations or adverse events occurred during the procedure.The patient was discharged with an indwelling catheter which was removed 8 days post the index procedure.It was reported that on the 8th day post procedure, the patient was reported to be experiencing worsening hesitancy, worsening urinary incontinence, worsening dribbling urine (weak stream), incomplete emptying of bladder and hematuria.At 16 days post the index procedure, the patient was also reported to be experiencing hematospermia.The patient symptom of hematospermia resolved 20 days post onset symptom, and the hematuria resolved 28 days post onset symptoms, both, without medical treatment.The remaining patient symptoms are still ongoing and no treatment has been administered.The facility investigator assessed the patient symptoms to be possibly related to the procedure and not related to the device.
 
Event Description
The patient underwent convective radiofrequency water vapor thermal therapy of the prostate.During procedure the patient was given iv sedation, pain medication and general anesthesia.A total of 12 treatments were delivered.No device observations or adverse events occurred during the procedure.The patient was discharged with an indwelling catheter which was removed 8 days post the index procedure.It was reported that on the 8th day post procedure, the patient was reported to be experiencing worsening hesitancy, worsening urinary incontinence, worsening dribbling urine (weak stream), incomplete emptying of bladder and hematuria.At 16 days post the index procedure, the patient was also reported to be experiencing hematospermia.The patient symptom of hematospermia resolved 20 days post onset symptom, and the hematuria resolved 28 days post onset symptoms, both, without medical treatment.The remaining patient symptoms are still ongoing and no treatment has been administered.The facility investigator assessed the patient symptoms worsening hesitancy, worsening dribbling urine (weak stream), incomplete emptying of bladder and hematuria and hematospermia to be possibly related to the procedure and not related to the device.The ongoing patient symptom of worsening urinary incontinence was assessed as unlikely related to the device and procedure.Independent medical reviewer (imr) adjudicated worsening hesitancy as probably related to the study treatment and unlikely related to study device.Worsening urinary incontinence was adjudicated as probably related to the study treatment and unlikely related to study device.Worsening of weak stream was adjudicated as probably related to the study treatment and unlikely related to study device.Hematuria was adjudicated as probably related to the study treatment and unlikely related to study device.
 
Manufacturer Narrative
B5 event description updated to reflect imr adjudications to worsening hesitancy, worsening urinary incontinence, worsening weak stream, and hematuria the device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.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 an evaluation conclusion code of known inherent risk of the device was assigned to this investigation.
 
Event Description
The patient underwent convective radiofrequency water vapor thermal therapy of the prostate.During procedure the patient was given iv sedation, pain medication and general anesthesia.A total of 12 treatments were delivered.No device observations or adverse events occurred during the procedure.The patient was discharged with an indwelling catheter which was removed 8 days post the index procedure.It was reported that on the 8th day post procedure, the patient was reported to be experiencing worsening hesitancy, worsening urinary incontinence, worsening dribbling urine (weak stream), incomplete emptying of bladder and hematuria.At 16 days post the index procedure, the patient was also reported to be experiencing hematospermia.The patient symptom of hematospermia resolved 20 days post onset symptom, and the hematuria resolved 28 days post onset symptoms, both, without medical treatment.The remaining patient symptoms are still ongoing and no treatment has been administered.The facility investigator assessed the patient symptoms worsening hesitancy, worsening dribbling urine (weak stream), incomplete emptying of bladder and hematuria and hematospermia to be possibly related to the procedure and not related to the device.The ongoing patient symptom of worsening urinary incontinence was assessed as unlikely related to the device and procedure.
 
Manufacturer Narrative
B5 event description updated to reflect device and procedure relationship update to worsening urinary incontinence.The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.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 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 Key9482871
MDR Text Key174399838
Report Number2937094-2019-61685
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 10/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
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
Date Manufacturer Received09/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age73 YR
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