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	11/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a water vapor therapy procedure, the generator did not allow the physician to perform the second prime, other kits were opened but the problem persisted.The procedure had to be canceled.There were no patient complications.This event is being reported for an aborted/canceled procedure with a patient under general anesthesia or whose sedation status was unknown.
Additional Manufacturer Narrative
The device was not available for analysis, therefore, no physical of the product could be performed.The reported device performed allegation cannot be determined.Based on the information available, the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that during a water vapor therapy procedure, the generator did not allow the physician to perform the second prime, other kits were opened but the problem persisted.The procedure had to be canceled.There were no patient complications.This event is being reported for an aborted/canceled procedure with a patient under general anesthesia or whose sedation status was unknown.
Additional Manufacturer Narrative
Upon receipt of the device at our quality assurance laboratory, this device was thoroughly analyzed.The device was functional test, and no other faulty conditions were identified.The service department was unable to confirm device damaged/defective.No defects were found.The generator received all required updates.The generator passed all functional and electrical safety testing.The evidence from the product record review did not identify a potential product quality issue or new patient harm.It can be concluded that the product operates as intended with no issues.
Event or Problem Description
It was reported that during a water vapor therapy procedure, the generator did not allow the physician to perform the second prime, other kits were opened but the problem persisted.The procedure had to be canceled.There were no patient complications.This event is being reported for an aborted/canceled procedure with a patient under general anesthesia or whose sedation status was 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: 20857946
• Report Number: 2124215-2024-74818
• Device Sequence Number: 18299510
• Product Code: GEI
• UDI-Device Identifier: 00855357006003
• UDI-Public: 00855357006003
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2025

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: 0000005806
• 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: 11/15/2024
• Supplement Date Received by Manufacturer: 12/16/2024; 02/14/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/02/2025; 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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: Male