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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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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 Abdominal Pain (1685); Urinary Retention (2119); Burning Sensation (2146); Hematuria (2558); Insufficient Information (4580)
Event Date 11/01/2021
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 are a known risk associated with water vapor therapy procedure and are 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 symptoms of hematuria, anejaculation, pain were 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 post a water vapor therapy procedure, the patient experienced irritative symptoms, blood in urine and was unable to ejaculate. The blood in the patient's urine resolved six days post procedure; however, the patient then developed urinary retention a few days after. The patient was catheterized. After removing the catheter, the patient was able to urinate in small amounts; however, experienced burning sensation when urinating. The patient also had lower abdominal pain after orgasms. After beginning medication to treat the patient's symptoms, the patient visited the emergency room (er) for side effects developed from the medication. The patient is now doing okay but is unable to ejaculate. After the patient's last visit to the er, the patient no longer experience tenderness in his prostate and other symptoms but is still not able to ejaculate.
 
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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 Key13002450
MDR Text Key282217281
Report Number2124215-2021-37678
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeFI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation
Type of Report Initial
Report Date 12/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received11/22/2021
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: 12/14/2021 Patient Sequence Number: 1
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