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

Model Number	G2200
Medical Device Problem Codes	Poor Quality Image (1408); Noise, Audible (3273); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a water vapor therapy procedure, after applying three treatments there was an issue with the generator causing the screen to glitch, the system to turn off, and there was a beeping sound.The procedure was not completed.There were no patient complications reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.
Event or Problem Description
It was reported that during a water vapor therapy procedure, after applying three treatments there was an issue with the generator causing the screen to glitch, the system to turn off, and there was a beeping sound.The procedure was not completed.There were no patient complications reported.This event is being reported for 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: 21293239
• Report Number: 2124215-2025-04634
• Device Sequence Number: 15755103
• Product Code: GEI
• UDI-Device Identifier: 08714729986850
• UDI-Public: 08714729986850
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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
• Device Lot Number: 0000003491
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 03/07/2025
• Date Device Manufactured: 07/25/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown