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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 Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2022
Event Type  malfunction  
Event Description
It was reported that prior a water vapor therapy, when the cystoscope with the camera was inserted, the delivery device shaft detached from the handpiece.Another delivery device was utilized to perform the procedure.There were no patient complications.
 
Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this delivery device underwent a thorough analysis.Visual inspection revealed the device returned without the shaft bearing and magnet components.Residue from the adhesive on the shaft from where the bearing was bonded, was observed.The pins in the connector were clean and straight.Based on the information available and analysis results, the missing shaft bearing identified in the delivery device confirmed to the reported clinical observation of shaft detachment.
 
Event Description
It was reported that prior a water vapor therapy, when the cystoscope with the camera was inserted, the delivery device shaft detached from the handpiece.Another delivery device was utilized to perform the procedure.There were no patient complications.
 
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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
MDR Report Key15556390
MDR Text Key301497249
Report Number2124215-2022-39668
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 Other,Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberD2201
Device Catalogue NumberD2201
Device Lot Number0029504227
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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