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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); Impotence (1925); Patient Problem/Medical Problem (2688)
Event Date 10/01/2017
Event Type  Injury  
Manufacturer Narrative
Date of event: actual event date is unknown.The patient reported that the surgery was performed in (b)(6) hospital, (b)(6), united states.The physician name is dr.(b)(6).
 
Event Description
It was reported that the patient underwent convective radiofrequency water vapor thermal therapy 3 years ago.The patient started bleeding and a catheter was placed post procedure.The catheter was removed 1 week post procedure.The bleeding stopped approximately 2 weeks post procedure.The patient had no more erection and ejaculation 6 weeks post procedure.No further information was provided.
 
Manufacturer Narrative
B3.Date of event: actual event date is unknown.The patient reported that the surgery was performed in (b)(6), united states.The physician name is (b)(6).The device was not returned for analysis.A review of the product labeling determined that hemorrhage, impotence and ejaculation (patient problem/medical problem) are noted as potential adverse events associated with the use of the device.Based on the available information, an evaluation conclusion code of known inherent risk of device was assigned to this event.
 
Event Description
It was reported that the patient underwent convective radiofrequency water vapor thermal therapy 3 years ago.The patient started bleeding and a catheter was placed post procedure.The catheter was removed 1 week post procedure.The bleeding stopped approximately 2 weeks post procedure.The patient had no more erection and ejaculation 6 weeks post procedure.No further information was provided.
 
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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 Key10950816
MDR Text Key219888078
Report Number2937094-2020-01039
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 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 11/10/2020
Initial Date FDA Received12/05/2020
Supplement Dates Manufacturer Received12/10/2020
Supplement Dates FDA Received12/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age74 YR
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