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	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a transurethral prostate steam treatment procedure for benign prostatic hyperplasia, while primming, there was no steam was emitted at all.Furthermore, steam should have been emitted from three directions, yet none came out but later, the device displayed the priming complete screen.An external needle was extended, similar to the internal one, and steam was sprayed, but no steam was emitted.The device delivery device was replaced but the issue persisted.Due to this, the procedure was not completed.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.This complaint is for the generator.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during a transurethral prostate steam treatment procedure for benign prostatic hyperplasia, while primming, there was no steam was emitted at all.Furthermore, steam should have been emitted from three directions, yet none came out but later, the device displayed the priming complete screen.An external needle was extended, similar to the internal one, and steam was sprayed, but no steam was emitted.It was attempted to use four different delivery devices, but the issue persisted and the generator could not be used for two operations.Due to this, the procedure was not completed.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.This complaint is for the generator.
Additional Manufacturer Narrative
The generator was received at manufacturing site for investigation.The generator passed all incoming tests and had the most current updates.The device passed all functional and electrical safety testing.Service history determined that the rezum generator was shipped to customer on 21nov2025.There were no other service reports available between date shipped and event date.The generator was fully functional until the reported event date 01dec2025.A review of the device instructions for use (ifu) was completed, there were no issues with the translation, wording or graphics.There was no evidence that the device was not used in accordance with the ifu.A risk review of the rezum hazard analysis was completed and confirmed that the event of damaged/defective was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on all available information, the reported allegation of not vapor coming out could not be confirmed, therefore, an investigation conclusion code of no problem detected was assigned to this investigation.Correction to field e4: init rptr also sent rep to fda.
Event or Problem Description
It was reported that during a transurethral prostate steam treatment procedure for benign prostatic hyperplasia, while primming, there was no steam was emitted at all.Furthermore, steam should have been emitted from three directions, yet none came out but later, the device displayed the priming complete screen.An external needle was extended, similar to the internal one, and steam was sprayed, but no steam was emitted.It was attempted to use four different delivery devices, but the issue persisted and the generator could not be used for two operations.Due to this, the procedure was not completed.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.This complaint is for 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): 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: 23863081
• Report Number: 2124215-2025-92246
• Device Sequence Number: 9285922
• Product Code: GEI
• UDI-Device Identifier: 08714729986874
• UDI-Public: (01)08714729986874(11)230123
• 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,Followup
• Report Date (Section B): 04/01/2026

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: 0000005300
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 12/01/2025; 03/03/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 12/23/2025; 04/02/2026
• Date Device Manufactured: 01/23/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown