MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Rezum; Electrosurgical, Cutting & Coagulation & Accessories

Model Number	G2200
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a water vapor therapy procedure, the delivery device did not produce steam when connected to the generator.It was noted that the generator was restarted and the connection was checked; however, the issue persisted.The procedure was not completed due to this event.There were no patient complications reported.This event is being reported for aborted/canceled procedure with a patient under anesthesia or sedation 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): NORTECH SYSTEM INC; nw 7791; 1450; minneapolis MN 55485 -779
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 25661388
• Report Number: 2124215-2026-34726
• Device Sequence Number: 5764800
• Product Code: GEI
• UDI-Device Identifier: 08714729986843
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: CA
• PMA/510(K) Number: K180237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2026

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: G2200
• Device Catalogue Number: G2200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Supplement Date Received by Manufacturer: 07/15/2026; 09/03/2026
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 08/13/2026; 09/22/2026
• Date Device Manufactured: 04/11/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REZUM DELIVERY DEVICE UNKNONW UPN/LOT
• Patient Sex: Unknown