MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M006D2201-003
Medical Device Problem Codes	Positioning Failure (1158); Retraction Problem (1536)
Health Effect - Clinical Code	Intraoperative Pain (2662)
Date of Event	03/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the needle was not retracting after the first treatment.The delivery device was unplugged, and it retracted, but it would not deploy.Another delivery device had to be opened.The procedure could not be completed because it was too painful for the patient.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Additional Manufacturer Narrative
The field (b5) describe event or problem was updated with additional information.Additional information was later received stating that the patient was not sedated at the time that the procedure was aborted.The patient was using nitrous.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the device in question.
Event or Problem Description
It was reported that the needle was not retracting after the first treatment.The delivery device was unplugged, and it retracted, but it would not deploy.Another delivery device had to be opened.The procedure could not be completed because it was too painful for the patient.Information was later received stating that the patient was not under general anesthesia when the procedure was cancelled, instead, the patient was using nitrous.

• Brand Name: REZUM
• Common Device Name: UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24825332
• Report Number: 2124215-2026-19277
• Device Sequence Number: 9139905
• Product Code: KNS
• UDI-Device Identifier: 08714729992547
• UDI-Public: (01)08714729992547(17)280103(10)38471411
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 04/09/2026

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: M006D2201-003
• Device Catalogue Number: M006D2201-003
• Device Lot Number: 0038471411
• 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: 03/18/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 04/09/2026
• Date Device Manufactured: 01/13/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown