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

Model Number	M006D2201-003
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: the exact date of the event is unknown.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that, upon inspection of inventory, the staff noticed a condensation or lube-like substance in the plunger piece in the rezum kit.There was no patient involved.
Additional Manufacturer Narrative
The delivery device associated with this report was not returned for analysis.However, a device from a separate complaint reporting the same alleged issue from the same site was returned and evaluated.The returned device was analyzed for the presence of the alleged foreign material.The analysis was performed using attenuated total reflectance infrared spectroscopy (atr-ir).The analysis identified the material observed in the syringe barrel as fluorosilicone lubricant, which is used during assembly of the syringe and is acceptable.Therefore, the reported allegation could not be confirmed.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The instructions for use were reviewed and did not reveal any evidence of device off-label use or failure to follow instructions.If the original complaint device is returned at a later date, the product investigation will be reopened to perform the appropriate analysis.Based on the available information, the manufacturer has determined that this event no longer meets reporting criteria for the device in question.B3.Date of event: the exact date of the event is unknown.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that upon inspection of inventory, the staff noticed a condensation or lube-like substance in the plunger piece in the rezum kit.There was no patient involved.

• 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: 23363473
• Report Number: 2124215-2025-75342
• Device Sequence Number: 8965203
• Product Code: KNS
• UDI-Device Identifier: 08714729992547
• UDI-Public: (01)08714729992547
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

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
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 01/15/2026
• 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