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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 Problems Defective Device (2588); Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/31/2022
Event Type  malfunction  
Event Description
It was reported that when the doctor placed the camera lens in the delivery device, a shadow was observed on the tip.The camera lens was changed for a new one but the same problem continued.It was found that a plastic on the tip of the delivery device was preventing viewing.The plastic preventing viewing was removed, and the case was completed with the broken tip.There were no patient complications.
 
Event Description
It was reported that when the doctor placed the camera lens in the delivery device, a shadow was observed on the tip.The camera lens was changed for a new one but the same problem continued.It was found that a plastic on the tip of the delivery device was preventing viewing.The plastic preventing viewing was removed, and the case was completed with the broken tip.There were no patient complications.
 
Manufacturer Narrative
Investigation summary: with the available information, boston scientific concludes that the delivery device broken tip is confirmed.However, analysis was not able to confirm the alleged plastic observed in the tip of the delivery device because it was not returned.Therefore a cause cannot be established.According to the reported event, the user removed the plastic material from the delivery device tip and completed the procedure with the broken delivery device tip.The instructions for use (ifu) instructs the user to not modify the device.Device history record (dhr) review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: the delivery device was returned and upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The device was returned with the yellow tip broken/cracked.Visual analysis revealed the delivery device handle was in overall good physical condition.The external tubing had no kinks.The pins in the connector were clean and straight.The delivery device buttons were pressed and sprang back with no issues.During functional testing, the retract/deploy functionality and the feel of the buttons were tested; the device passed priming and worked normally pass the full 5 treatments with no issues.The backplate and top housing of the delivery device were removed for internal visual inspection; all internal components appeared normal.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off-label use, or that the guidance in the ifu was not followed.Investigation conclusion: based on the analysis results and information available, the reported event is confirmed.A conclusion code of cause not established was assigned to this investigation.
 
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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
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 Key13615109
MDR Text Key286234095
Report Number2124215-2022-05652
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeCI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/07/2023
Device Model NumberD2201
Device Catalogue NumberD2201
Device Lot Number0027751477
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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