MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Rezum; Unit, Electrosurgical Endoscopic (With Or Without Accessories)

Model Number	M006D2201-0032
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a water vapor therapy procedure for benign prostatic hyperplasia was completed, the patient presented a bleeding, and transurethral coagulation was performed after blood transfusion.No further information about the patient and procedure outcome was provided.

• 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; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50072602
• Report Number: 2124215-2026-40637
• Device Sequence Number: 18714007
• Product Code: KNS
• UDI-Device Identifier: 00191506006785
• UDI-Public: (01)00191506006785
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191505
• 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
• Report Date (Section B): 09/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M006D2201-0032
• Device Catalogue Number: M006D2201-0032
• 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: 07/14/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 09/03/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown