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

Model Number	G2200
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation, the device displayed an error code 275 (syringe water fill error).It was also noted that, after replacing the delivery device and rebooting, the situation did not change.The procedure was not completed due to this event.There was no report of patient complications.This event is being reported for aborted/canceled procedure with a patient under anesthesia or sedation unknown.
Event or Problem Description
It was reported that during preparation, the device displayed an error code 275 (syringe water fill error).It was also noted that, after replacing the delivery device and rebooting, the situation did not change.The procedure was not completed due to this event.The patient was under spinal anesthesia and there was no report of patient complications.Boston scientific has been unable to obtain additional information regarding the procedure and patient outcome, despite good faith efforts.This event is being reported for aborted/canceled procedure with a patient under anesthesia or sedation.
Event or Problem Description
It was reported that during preparation, the device displayed an error code 275 (syringe water fill error).It was also noted that, after replacing the delivery device and rebooting, the situation did not change.The procedure was not completed due to this event.The patient was under spinal anesthesia and there was no report of patient complications.Boston scientific has been unable to obtain additional information regarding the procedure and patient outcome, despite good faith efforts.This event is being reported for aborted/canceled procedure with a patient under anesthesia or sedation.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the generator was thoroughly analyzed.The complaint against the generator was confirmed.No water pressure was shown.The load cell and its associated cables were replaced, which resolved the issue.The generator had already received all necessary updates and was in overall good physical condition.It passed both functional and electrical safety tests.Later, the generator was returned and underwent a visual inspection, which revealed no damage or abnormalities.However, during functional testing, error 275 appeared on the screen, indicating that the pressure value of 250mmhg was not reached during the prime stage prior to vapor generation.Based on these findings, it can be concluded that the electrical failure was the most probable cause of the complaints.Based on the information available, the investigation conclusion code assigned is cause traced to component failure.

• 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: 22004518
• Report Number: 2124215-2025-30219
• Device Sequence Number: 15728213
• Product Code: GEI
• UDI-Device Identifier: 08714729986874
• UDI-Public: (01)08714729986874(11)220915
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2026

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
• 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: 04/21/2025
• Supplement Date Received by Manufacturer: 05/22/2025; 01/20/2026
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/17/2025; 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown