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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 Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/04/2021
Event Type  malfunction  
Event Description
It was reported that after connecting the delivery device to the generator for a water vapor therapy prostate treatment, error 235 code prompted on the generator screen. The water did not get hot enough to perform the initial water vapor treatment with the delivery device. A second delivery device was tried; however, 35002 error code prompted on the generator screen. The procedure was cancelled and the patient was under sedation when the error codes occurred. Although the patient was under sedation at the time, there were no complications to the patient as a result of the event. This event is being reported for aborted/cancelled procedure with a patient under anesthesia.
 
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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 Key12103806
MDR Text Key259579298
Report Number2124215-2021-18060
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberD2201
Device Catalogue NumberD2201
Device Lot Number0026955317
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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