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	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.G4 premarket/510k: k190093, k191505.
Event or Problem Description
It was reported that when the supply team received a box of 5 rezum kits upon arrival, the supply team examined the kits without opening them and noticed moisture in the plunger.The procedures were cancelled until future notice due to the damaged product upon arrival at the facility.There were no patient complications.Device 4 of 5.
Event or Problem Description
It was reported that when the supply team received a box of 5 rezum kits upon arrival, the supply team examined the kits without opening them and noticed moisture in the plunger.The procedures were cancelled until future notice due to the damaged product upon arrival at the facility.There were no patient complications.Device 4 of 5.
Additional Manufacturer Narrative
G1.Manufacturing site: correction.G4 premarket/510k: k190093, k191505.Upon receipt, this product was thoroughly analyzed in our quality assurance laboratory.Analysis of the returned device did not confirm the reported clinical observation.The rezum kit was returned in an unopened sealed package.The syringe barrel component was visually inspected and sent to the arden hills analytical lab (ahal) to analyze the alleged moisture that was visible inside the syringe barrel of the returned sample.The syringe barrel component of the returned device was analyzed using attenuated total reflectance infrared spectroscopy (atr-ir).This analysis found the alleged substance in the syringe barrel to be consistent with fluorosilicone lubricant.Nusil med 400 is a fluorosilocone lubricant and is part of the bill of materials (bom).This material has been characterized and determined to be biocompatible and is used in the assembly of the syringe component of the device.Per boston scientific work instruction 92271201, silicone lubricant in the syringe barrel is acceptable.The review completed on the device history review (dhr) for this device confirmed that it met specification prior to release.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the reported foreign material present in device event.Based on the information available and analysis results, boston scientific concludes that no foreign material was present in the device and therefore, a conclusion code of device problem excluded 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; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23589182
• Report Number: 2124215-2025-83207
• Device Sequence Number: 18491267
• 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): 01/09/2026

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 Expiration Date: 02/28/2026
• Device Model Number: M006D2201-003
• Device Catalogue Number: M006D2201-003
• Device Lot Number: 0037457222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2023
• 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