MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Rezum; Electrosurgical, Cutting & Coagulation & Accessories

Model Number	G2200
Medical Device Problem Codes	No Display/Image (1183); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during procedure, upon connecting the gray cable of the delivery device, the screen blacked out.After rebooting, a 275 error occurred, making the device unusable.Even after replacing the delivery device with three different cables, the situation remained unchanged.The procedure was cancelled due to this event after general anesthesia was administered.This event is being reported for aborted/cancelled procedure with a patient under general anesthesia.
Event or Problem Description
It was reported that, during procedure, upon connecting the gray cable of the delivery device, the screen blacked out.After rebooting, a 275 (syringe water fill error) error occurred, making the device unusable.Even after replacing the delivery device with three different cables, the situation remained unchanged.The procedure was cancelled due to this event.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; nw 7791; 1450; minneapolis MN 55485 -779
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24795473
• Report Number: 2124215-2026-18685
• Device Sequence Number: 21293147
• Product Code: GEI
• UDI-Device Identifier: 08714729986874
• UDI-Public: (01)08714729986874(11)241217
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2026

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
• Device Lot Number: 0000006649
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/28/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 04/06/2026; 09/08/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 05/04/2026; 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male