MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	G2200
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a water vapor therapy procedure, error 495 (rf power supply self-test error) was displayed.It was unclear whether the error was caused by a problem with the generator or the delivery device.The delivery device was unpacked and connected to the generator, but the issue persisted, so the procedure was not completed.There were no patient complications.
Additional Manufacturer Narrative
B5.Describe event or problem: corrected.
Event or Problem Description
It was reported that, during a water vapor therapy procedure, error 495 (rf power supply self-test error) was displayed.It was unclear whether the error was caused by a problem with the generator or the delivery device.The delivery device was unpacked and connected to the generator, but the issue persisted, so the procedure was not completed.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.

• Brand Name: REZUM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22631671
• Report Number: 2124215-2025-49628
• Device Sequence Number: 8936780
• Product Code: GEI
• UDI-Device Identifier: 08714729986867
• UDI-Public: (01)08714729986867(11)240213
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180237
• 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): 09/17/2025

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: G2200
• Device Catalogue Number: G2200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 09/17/2025
• Date Device Manufactured: 02/13/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REZUM SINGLE USE DEVICE, LOT 0034893632; REZUM SINGLE USE DEVICE, LOT 0034893632
• Patient Sex: Unknown