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

Model Number	G2200
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
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 error codes mentioned, even during the device incoming functional testing.However, the generator passed the power on self-test (post).The syringe and delivery device were connected with no issues overserved and the device primed and flush as per specifications.Reviewing the event logs, there were found errors 219 (resonant frequency less than 410 khz or greater than 460 khz), 235 (coil temperature is below 105 or outlet temp is below 90 during vapor prime), 250 (vapor button released during prime sequence) and 275 (empty limit switch indicates the syringe limit is empty error codes) but there were no other service records for this generator.As a precaution the internal delivery device cable and load cell were replaced, and the system device was updated.The generator passed full functional and electrical safety testing.It is likely that the error message resulted from an electrical issue, leading to the reported event.The reported complaint was not confirmed.Based on review of all information available and analysis results, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that there was an error message displayed.There were no patient complications.The procedure aborted due to malfunction.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.
Event or Problem Description
It was reported that there was an error message displayed.There were no patient complications.The procedure aborted due to this malfunction.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.

• 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: 21213953
• Report Number: 2124215-2025-02746
• Device Sequence Number: 3466904
• Product Code: GEI
• UDI-Device Identifier: 08714729986843
• UDI-Public: (01)08714729986843(11)230206(21)5310
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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: 0000005310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown