MAUDE Adverse Event Report: US ENDOSCOPY; QUICK CATCH IN-LINE SUCTION POLYP TRAP

Model Number	710201
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure the polyp was not properly suctioned through their quick catch in-line suction polyp trap resulting in a procedure delay.The polyp was unable to be located.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event was not returned to steris for evaluation.Without the returned device, the cause of the reported event cannot be determined.The quick catch in-line suction polyp trap instructions for use states, "prior to clinical use, inspect and familiarize yourself with the device.If there is evidence of damage (i.E.Deformed, cracked, kinked tubing, damaged packaging), do not use this product and contact your local product specialist." the dhr for the lot subject of the event was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.A complaint review confirmed this to be an isolated event for the subject lot.No additional issues have been reported.

• Brand Name: NA
• Common Device Name: QUICK CATCH IN-LINE SUCTION POLYP TRAP
• 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: 22913404
• Report Number: 1528319-2025-00090
• Device Sequence Number: 12977534
• Product Code: KDQ
• UDI-Device Identifier: 00724995184704
• UDI-Public: (01)00724995184704(11)250410(10)12238859
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 710201
• Device Catalogue Number: 710201
• Device Lot Number: (10)12238859
• 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: 07/30/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2025
• 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