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

Model Number	G2200
Medical Device Problem Codes	Mechanical Problem (1384); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a water vapor therapy procedure for benign prostatic hyperplasia procedure, the roller was not working and there was an unusual noise and error code 455-saline pump self-test error was displayed.The console was rebooted, but the error persisted.There were no patient complications, however, the procedure was postponed.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia.
Additional Manufacturer Narrative
Upon receipt of this generator at our quality assurance laboratory, this device was thoroughly analyzed.The generator was tested and was unable to replicate the 455 roller pump encoder indicates the roller pump is not turning during the power-up error code or any noise from the roller pump.The generator passed the power on self-test and could prime and flush as intended.The generator event logs were checked, and the error code 455 was found in multiple times.After a deep investigation, it was determinate that a contact in a cable was not fully seated in the connector, leading to the intermittent 455 error.The contact was reseated in the connector and that resolved the error, thus, confirming the reported event that led to the procedure cancelled.The generator was updated and passed all functional and electrical safety testing.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.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 completed and confirmed that the event of device displays 455 saline pump self-test error and noise issue are defined in the risk documentation.Based on the information available, a conclusion code of cause linked to device but unable to trace more specifically was assigned to this investigation.
Event or Problem Description
It was reported that during a water vapor therapy procedure for benign prostatic hyperplasia procedure, the roller was not working and there was an unusual noise and error code 455-saline pump self-test error was displayed.The console was rebooted, but the error persisted.There were no patient complications, however, the procedure was postponed.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia.

• 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: 23694937
• Report Number: 2124215-2025-84104
• Device Sequence Number: 9123690
• Product Code: GEI
• UDI-Device Identifier: 08714729986874
• UDI-Public: (01)08714729986874(11)250128
• 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): 03/27/2026

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
• Device Lot Number: 0000006706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown