Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDPLAST MEDICAL, INC. REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Urinary Retention (2119); Discomfort (2330); Patient Problem/Medical Problem (2688)
Event Date 10/18/2018
Event Type  Injury  
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 the same day post convective radiofrequency water vapor thermal therapy procedure, the patient experienced urinary discomfort for which medication (unknown type and dose) was administered.The symptom of urinary discomfort was reported to have resolved 22 days post onset symptom.The patient symptom of urinary discomfort was assessed as probable treatment and device related.
 
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
The patient underwent convective radiofrequency water vapor thermal therapy procedure.During procedure, the patient was administered iv sedation and general anesthesia.A total of 11 treatments were delivered.No device observations or adverse events occurred during treatment.It was reported that the same day post procedure the patient experienced urinary discomfort for which 118mg of uribel was administered at discharge.At 10 days post the index procedure, the patient was reported to have experienced difficulty voiding for which tamsulosin bid (dose unknown) was administered.At 23 days post the index procedure, the patient was reported to be experiencing worsening of decrease ejaculatory volume and worsening of erectile dysfunction for which tamsulosin prn (dose unknown) was administered.The patient symptom of difficulty voiding resolved 11 days post onset symptom, and the urinary discomfort resolved 21 days post onset symptom.The worsening of decrease ejaculatory volume and worsening of erectile dysfunction are still on going.The investigator assessment of the patient symptoms of urinary discomfort was assessed as probable procedure and device related.The patient symptom of difficulty voiding was assessed as possible procedure related, the patient symptom of worsening of decrease ejaculatory volume was assessed as possible procedure related, the patient symptom of worsening of erectile dysfunction was assessed as unlikely procedure relate.The clinical event committee (cec) assessed the patient urinary discomfort as a non-event, the difficulty voiding as possibly related to the study treatment, the worsening of decrease ejaculatory volume as a non-event, and the worsening of erectile dysfunction symptom as possibly related to the study treatment.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8824643
MDR Text Key152174402
Report Number2937094-2019-60915
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
Report Date 09/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2019
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
Date Manufacturer Received08/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age66 YR
-
-