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

Model Number	G2200
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, a low-temperature error prompted, and no steam was emitted.The issue persisted even after restarting device.The procedure was not completed due to this event.Additional information noted that the patient was temporarily discharged and is scheduled for a reoperation on a different date.There was no report of patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation.
Event or Problem Description
It was reported that during procedure, a low-temperature error prompted, and no steam was emitted.The issue persisted even after restarting device.The procedure was not completed due to this event.Additional information noted that the patient was temporarily discharged and is scheduled for a reoperation on a different date.There was no report of patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.The rezum console was installed on 6/6/2025.There were no other service reports available.The console was fully functional until the reported event date of issue, 11/18/2025.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.A risk review was performed and confirmed that the event of the device displaying an error message was defined in the product risk and documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available, the cause that contributed to the reported event cannot be established.

• 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 7791
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23804982
• Report Number: 2124215-2025-90875
• Device Sequence Number: 7622317
• Product Code: GEI
• UDI-Device Identifier: 08714729986843
• UDI-Public: (01)08714729986843(11)171204
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 03/09/2026
• Date Device Manufactured: 12/04/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown