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

Model Number	M006D2201-003
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis could be performed as the complaint component was not returned for analysis.The reported allegations could not be confirmed.A risk review was completed and confirmed that the event of failure to retract during procedure/ manual retraction failed was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.The allegation of failure to retract during procedure/ manual retraction failed is unable to be confirmed due to the lack of a product return to analyze.Additionally, the evidence from the product record review did not identify a potential product quality issue or new patient harm.It can be concluded that at this point that unknown factors most probably contributed to the complaint/event.Without a returned product available for analysis and based on this investigation a clear probable cause for the event cannot be established; therefore, the conclusion code of unable to exclude device problem has been chosen.
Event or Problem Description
It was reported that the needle wouldn't retract when connecting the device to the generator.The device was disconnected and reconnected, but it did not work.Manual retraction was attempted but it was unsuccessful.The procedure was completed with another device.There were no patient complications.

• 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: 24425609
• Report Number: 2124215-2026-10045
• Device Sequence Number: 9905304
• Product Code: KNS
• UDI-Device Identifier: 08714729992547
• UDI-Public: (01)08714729992547(17)260228(10)37409008
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K190093
• 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
• Report Date (Section B): 02/24/2026

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: 0037409008
• 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: 01/27/2026
• Initial Report FDA Received Date: 02/24/2026
• 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