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

Model Number	G2200
Medical Device Problem Code	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 the unit stopped in middle of the water vapor therapy procedure.The saline solution was restocked, and the unit reprimed, but still not worked.Therefore, the procedure could not be completed.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Additional Manufacturer Narrative
Upon receipt of this generator at our quality assurance laboratory, this device was thoroughly analyzed.The service department was unable to replicate the generator stopping during procedure fault condition.There was no error codes displayed during the incoming functional testing.The generator passed the post (power on self-test).The syringe and delivery device were connected with no issues.The generator primed and flush as per specifications.This generator received all required updates as per upgrade checklist and plastic enclosure upgrades.The product was in overall good physical condition and passed full all the functional and electrical safety testing.It is suspected that the issue was with the handpiece used.Based on the analysis results of this device, the reported event was not confirmed.Therefore, the investigation conclusion code assigned is no problem detected.
Event or Problem Description
It was reported that the unit stopped in middle of the water vapor therapy procedure.The saline solution was restocked, and the unit reprimed, but still not worked.Therefore, the procedure could not be completed.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under general 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; 925 6th avenue ne; milaca 56353
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21364150
• Report Number: 2124215-2025-06006
• Device Sequence Number: 8563762
• Product Code: GEI
• UDI-Device Identifier: 08714729986850
• UDI-Public: (01)08714729986850(11)180725(21)3491
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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