MAUDE Adverse Event Report: US ENDOSCOPY DUOSWIFT; CLEANING BRUSH

Model Number	00711618
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The duoswift cleaning brush was not available for evaluation.Without the return of the full device a cause of the event could not be determined.User facility personnel stated that the scope in which the squeegee was found had no issues during pre-procedure testing.Steris offered in-service training on the proper use and handling of the duoswift cleaning brush, however, the user facility declined.No additional issues have been reported.Udi related data clarification - the lot/serial number is unknown; therefore, the applicable production identifiers were not included in the mdr.
Event or Problem Description
The user facility reported that during a patient procedure, the squeegee portion of a duoswift cleaning brush was "lodged" in the channel of the scope.User facility personnel utilized another scope, and the patient procedure was completed successfully.No report of injury.

• Brand Name: DUOSWIFT
• Common Device Name: CLEANING BRUSH
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor 44060 ; 4403586251
• MDR Report Key: 22921450
• Report Number: 1528319-2025-00091
• Device Sequence Number: 16049682
• Product Code: MNL
• UDI-Device Identifier: 00724995185039
• UDI-Public: (01)00724995185039
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2025

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: 00711618
• Device Catalogue Number: 00711618
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 09/17/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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