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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
Model Number D2201
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Urinary Retention (2119); Dysuria (2684); Cramp(s) /Muscle Spasm(s) (4521)
Event Date 01/14/2022
Event Type  Injury  
Event Description
It was reported by the patient that he underwent a water vapor therapy procedure. The device worked as intended during the procedure. The patient was catheterized until five days post procedure. The catheter was removed five days post procedure and the patient was not able to void himself. A catheter was reinserted and removed ten days post procedure. The patient still could not void himself and was instructed to self-catheterize. Thirteen days post procedure the patient was able to dribble a small amount of urine. The dribbling of small amount continued through sixteen days post procedure at which time he was able to produce a small stream, but not enough to empty his bladder. The flow had strengthened afterward, and the patient had not catheterized since sixteen days post procedure. The urine flow closed down at night, and the patient had to strain to produce very little urine. The patient had bad bladder spasms before and during urination and stinging during urination. The bladder spasms and the stinging had eased somewhat later.
 
Event Description
It was reported by the patient that he underwent a water vapor therapy procedure. The device worked as intended during the procedure. The patient was catheterized until five days post procedure. The catheter was removed five days post procedure and the patient was not able to void himself. A catheter was reinserted and removed ten days post procedure. The patient still could not void himself and was instructed to self-catheterize. Thirteen days post procedure the patient was able to dribble a small amount of urine. The dribbling of small amount continued through sixteen days post procedure at which time he was able to produce a small stream, but not enough to empty his bladder. The flow had strengthened afterward, and the patient had not catheterized since sixteen days post procedure. The urine flow closed down at night, and the patient had to strain to produce very little urine. The patient had bad bladder spasms before and during urination and stinging during urination. The bladder spasms and the stinging had eased somewhat later.
 
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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 Key13563928
MDR Text Key285984146
Report Number2124215-2022-05146
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191505
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberD2201
Device Catalogue NumberD2201
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/25/2022
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: 02/18/2022 Patient Sequence Number: 1
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