• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 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
 

BOSTON SCIENTIFIC CORPORATION REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)
Event Date 08/10/2021
Event Type  Injury  
Manufacturer Narrative
Investigation summary: based on the information available, there was no device available for analysis and there was no report of a device performance allegation during treatment. The reported patient symptoms is a known risks associated with water vapor therapy procedures and is noted as such in the device instructions for use. Device history record (dhr): a dhr and ship history review cannot be performed as the lot number was not available. Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed. Labeling review: the delivery device instructions for use (ifu) was reviewed. The patient symptom of hematuria was found to be listed in the ifu. Investigation conclusion: based on the information available, a conclusion code of known inherit risk of device was assigned to this investigation.
 
Event Description
It was reported that during a water vapor therapy procedure, the physician pushed too hard past the right sulcus navigating over the median lobe tearing the mucosa. However, false passage did not occur in the mucosa due to the reported delivery device manipulation. After completing the water vapor therapy procedure, the physician felt it was necessary to use a bipolar transurethral resection of the prostate (turp) to cauterize the bleeding vessel. The bleeding stopped and the patient was sent to recovery. The patient is expected to fully recover and was not admitted beyond the standard of care.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREZUM
Type of DeviceUNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer Contact
alyson harris
4100 hamline avenue north
building c
saint paul, MN 55112
4089353452
MDR Report Key12388737
MDR Text Key268874599
Report Number2124215-2021-25804
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/30/2021 Patient Sequence Number: 1
-
-