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 Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/23/2019
Event Type  malfunction  
Event Description
It was reported that prior to convective radiofrequency water vapor thermal therapy treatment of the prostate, the plastic flake was noted to be coming off from the device when the scope was inserted into the back of the device.The device was never inserted into the patient.The procedure was completed utilizing a second device without clinical consequences to the patient.
 
Manufacturer Narrative
The device was not returned so no physical analysis could be performed.Based on the review of a photo image provided by the customer, it appears that most likely a fragment of the silicon flaps, which are at the scope entry point on the delivery device, broke off and was pushed into the shaft by the scope.A review of the device history record confirmed that the device met all material, assembly and performance specifications prior to release.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.Based on the information available, an evaluation conclusion code of cause not established was assigned to this investigation.
 
Event Description
It was reported that prior to convective radiofrequency water vapor thermal therapy treatment of the prostate, the plastic flake was noted to be coming off from the device when the scope was inserted into the back of the device.The device was never inserted into the patient.The procedure was completed utilizing a second device without clinical consequences to the patient.
 
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 Key8620547
MDR Text Key145405887
Report Number2937094-2019-60635
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 health professional,user faci
Type of Report Initial,Followup
Report Date 09/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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 Received08/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-