MAUDE Adverse Event Report: US ENDOSCOPY DUOSWIFT; DUOSWIFT CLEANING BRUSH

Model Number	00711619
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation determined that the facility utilizes the duoswift cleaning brush to clean their endoscopes.The piece retrieved during the procedure appeared to be the "bladed end" (squeegee portion) of a duoswift brush.It appears that the brush detached and become lodged in the scope but was not noticed by user facility personnel during cleaning or subsequent sterilization.Both the original brush and the broken piece subject of the event were discarded by user facility personnel.Without the return or inspection of the subject device, a root cause cannot be determined.The instructions for use states, "review original equipment manufacturer's guidelines regarding the care and cleaning of individual endoscope channels prior to the use of any cleaning brush." a three-year complaint review was completed and confirmed this to be an isolated event.Steris will counsel user facility personnel on the importance of cleaning and the handling of their duoswift cleaning brush.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure a piece of a cleaning brush dislodged from the endoscope inside a patient and had to be retrieved.The broken piece was retrieved successfully.No report of injury.
Additional Manufacturer Narrative
A steris account manager counseled user facility personnel on the importance of ensuring the cleaning brush is intact after each use.No additional issues have been reported.

• Brand Name: DUOSWIFT
• Common Device Name: DUOSWIFT 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 ; 4404130648
• MDR Report Key: 21182432
• Report Number: 1528319-2025-00004
• Device Sequence Number: 11833997
• Product Code: MNL
• UDI-Device Identifier: 00724995185046
• UDI-Public: (01)00724995185046(11)240816(17)270816(10)10907220
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 01/17/2025

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: 00711619
• Device Catalogue Number: 00711619
• Device Lot Number: (10)10907220
• 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: 12/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2024
• 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