MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M006D2201-003
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during the water vapor thermal therapy procedure, the needle failed to retract.It was noted that the patient was showing a little discomfort during the procedure, so the physician decided to finish the procedure.The physician was able to remove the delivery device by pulling the needle safety pin and manually retracting the needle.There were no further patient complications.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.

• Brand Name: REZUM
• Common Device Name: 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24783593
• Report Number: 2124215-2026-18399
• Device Sequence Number: 6133534
• Product Code: KNS
• UDI-Device Identifier: 08714729992547
• UDI-Public: (01)08714729992547(17)271007(10)38108674
• Combination Product (Y/N): N
• PMA/510(K) Number: K191505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M006D2201-003
• Device Catalogue Number: M006D2201-003
• Device Lot Number: 0038108674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male