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

Model Number	G2200
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, prior to a procedure, the customer observed that the irrigation was not flowing.Troubleshooting was performed, and it was confirmed that the customer was following the steps correctly.However, irrigation stil would not flow through the device.Then, it was further attempted to deploy the needle in hopes irrigation would automatically flow, but it did not work.A second delivery device was used and had the same irrigation issue.It was noted that this is likely a roller pump issue with the generator.The procedure was cancelled, and the patient was already under general anesthesia.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under general anesthesia.
Event or Problem Description
It was reported that, prior to a procedure, the customer observed that the irrigation was not flowing.Troubleshooting was performed, and it was confirmed that the customer was following the steps correctly.However, irrigation still would not flow through the device.Then, it was further attempted to deploy the needle in hopes irrigation would automatically flow, but it did not work.A second delivery device was used and had the same irrigation issue.It was noted that this is likely a roller pump issue with the generator.The procedure was cancelled, and the patient was already under general anesthesia.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 MN 56353
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22022772
• Report Number: 2124215-2025-30805
• Device Sequence Number: 21027479
• Product Code: GEI
• UDI-Device Identifier: 00855357006003
• UDI-Public: (01)00855357006003(11)230919
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 06/20/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/20/2025
• Date Device Manufactured: 09/19/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown