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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 Hemorrhage/Bleeding (1888); Urinary Retention (2119); Urinary Frequency (2275)
Event Date 08/17/2020
Event Type  Injury  
Event Description
It was reported that following a convective radiofrequency water vapor thermal therapy procedure, the patient had a catheter until (b)(6) 2020.After the catheter was removed, the patient experienced bleeding for a week or so and was urinating 10-12 times a day.The urine amounts varied from 40cc to 180-200 cc, and in some cases, the amount was 200 to 220 cc and once at 300cc.The patient reported initially waking up three times a night to urinate various amounts, then twice a night, and then only once in the last three nights.This was the only improvement the patient experienced in almost two months.No further patient complications were reported.
 
Manufacturer Narrative
The evidence from the product record review did not identify a potential product quality issue or new patient harm.
 
Event Description
It was reported that following a convective radiofrequency water vapor thermal therapy procedure, the patient had a catheter until (b)(6) 2020.After the catheter was removed, the patient experienced bleeding for a week or so and was urinating 10-12 times a day.The urine amounts varied from 40cc to 180-200 cc, and in some cases, the amount was 200 to 220 cc and once at 300cc.The patient reported initially waking up three times a night to urinate various amounts, then twice a night, and then only once in the last three nights.This was the only improvement the patient experienced in almost two months.No further patient complications were reported.
 
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Brand Name
REZUM
Type of Device
UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10892340
MDR Text Key217951413
Report Number2937094-2020-01012
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 consumer
Type of Report Initial,Followup
Report Date 12/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberD2201
Device Catalogue NumberD2201
Was Device Available for Evaluation? No
Date Manufacturer Received11/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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