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

Model Number	M006D2201-0032
Medical Device Problem Codes	Mechanical Problem (1384); Communication or Transmission Problem (2896)
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, an error code 375 occurred repeatedly.It was indicated that the procedure was not completed due to another reason.There were no patient complications.No further information was provided.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation unknown.
Event or Problem Description
It was reported that during procedure, an error code 275 (syringe water fill error) occurred repeatedly.The procedure was not completed due and was rescheduled for a later date.There were no patient complications reported due to this event.No further information was provided.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.
Additional Manufacturer Narrative
Correction to field b5: describe event or problem correction to field h6: device codes the device was not returned for analysis; therefore, no visual or functional testing was able to be completed.The device history record confirmed that the device met with all manufacturing specifications prior to distribution and there were no manufacturing deviations.The instructions for use were reviewed and did not reveal any evidence of device off-label use or failure to follow instructions.A risk review was completed and confirmed that the event of device displays 275 syringe water fill error was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.With all the available information, boston scientific concludes that the reported complaint was not confirmed.Based on the information available, an investigation conclusion code of cause not established was assigned to this investigation.

• 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: 24770255
• Report Number: 2124215-2026-18268
• Device Sequence Number: 10268521
• Product Code: KNS
• UDI-Device Identifier: 00191506006785
• UDI-Public: (01)00191506006785(17)271007(10)38191871
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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: M006D2201-0032
• Device Catalogue Number: M006D2201-0032
• Device Lot Number: 0038191871
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 05/12/2026
• Date Device Manufactured: 10/17/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR: UPN: G2200-003Z, SERIAL NUMBER: (B)(6).
• Patient Age: 78 YR
• Patient Sex: Male