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

Model Number	G2200
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the water vapor thermal therapy procedure, no steam was emitted during the 8th and 9th shots.During these shots, the countdown sound did not play, and it seemed to be in standby mode.The device was removed once, and the steam was activated outside the body to confirm that it was spraying, then it was reinserted, and puncture was performed again, but it still seemed that no steam was emitted.Bleeding from the final shot site did not stop and eventually required hemostasis.The procedure was completed with this device.This complaint refers to the generator.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The no steam produced fault condition could not be replicated.However, data logs confirm that vapor was not generated at the times alleged in the complaint.The reported allegation was confirmed.During functional testing, no error codes appeared.Sound was generated at expected times during use.There were no issues with sound circuits.The generator passed the post (power on self-test).Syringe and delivery device were connected with no issues.Generator primed and flush as per specifications.The generator requires several updates.The generator was in overall good physical condition and passed full functional and electrical safety testing.The generator logs showed that for the 8th treatment attempt the reason that no vapor was produced was because the user did not have the needle deployed.Attempting to deliver vapor without the needle deployed is evidence of failure to follow the instructions for use of the delivery device which instructs the user to press the vapor activation button after the needle has been deployed.For the 9th and 11th treatments attempts the logs show that shortly after pressing the vapor activation button the generator went into the "pending ready" state which per the generator instructions for use, if at any time the generator is not ready to perform a treatment the screen specified waiting as depicted below and is grayed out.The generator will automatically be ready for treatment when the pending condition is resolved.The logs show that for the 9th and 11th treatments the user attempted to initiate treatment too soon after pressing the needle deployment button, as there was only a 0.5 second time difference between pressing the deploy and vapor activation buttons.This short time span suggests the user was attempting to deliver vapor at the moment the needle was deployed from the delivery device.With such a short time between pressing the deploy button and the vapor activation button the generator was not able to recognize if the needle had deployed yet and therefore entered the pending ready state until it could verify the needle was deployed.Had the user released the vapor activation button per the alert message on the generator screen it would have put the generator in the "ready" state and the user could then proceed with the treatment like normal, however the user did not release the vapor activation button and continued to hold it for the length of a treatment which is a failure to follow the instructions contained within the generator instructions for use.Additionally, the reported patient symptoms are a known risk associated with these devices as indicated in the instructions for use.Based on the information available, a conclusion code of failure to follow instructions was assigned to this investigation.The allegation of blood loss is being assigned a cause code of known inherent risk of device.
Event or Problem Description
It was reported that during the water vapor thermal therapy procedure, no steam was emitted during the 8th and 9th shots.During these shots, the countdown sound did not play, and it seemed to be in standby mode.The device was removed once, and the steam was activated outside the body to confirm that it was spraying, then it was reinserted, and puncture was performed again, but it still seemed that no steam was emitted.Bleeding from the final shot site did not stop and eventually required hemostasis.The procedure was completed with this device.This complaint refers to the generator.

• 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: 22566788
• Report Number: 2124215-2025-48551
• Device Sequence Number: 13070915
• Product Code: GEI
• UDI-Device Identifier: 08714729986874
• UDI-Public: (01)08714729986874
• 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): 11/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown