MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. QUICK CATCH IN-LINE SUCTION POLYP TRAP

Model Number	710201
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
User facility personnel were able to successfully retrieve the suctioned polyp.The quick catch in-line suction polyp trap subject of the reported event was not returned for evaluation.Without the return of the device a root cause cannot be determined.A complaint review confirmed this to be an isolated event for the subject lot.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure, a nurse observed that the screen was missing from the quick catch in-line suction polyp trap subsequently causing the removed polyp to become lodged in the manifold of the suction device.The patient procedure was completed successfully following a procedure delay.No report of injury.

• Brand Name: QUICK CATCH IN-LINE SUCTION POLYP TRAP
• Common Device Name: QUICK CATCH IN-LINE SUCTION POLYP TRAP
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 18247342
• Report Number: 1528319-2023-00047
• Device Sequence Number: 17919374
• Product Code: KDQ
• UDI-Device Identifier: 00724995184704
• UDI-Public: 00724995184704
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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): 12/01/2023

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: 710201
• Device Lot Number: 7019766
• 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: 11/06/2023
• Initial Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2023
• 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