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

Model Number	710201
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via user facility medsun report the following, "trap used to catch snared polyps did not have netting and did not catch resected polyp.Polyp had to be fished out of suction canister and could have been lost without ability of pathology to examine.".
Additional Manufacturer Narrative
Steris became aware of this event on june 20, 2022 through our periodic review of the medsun database.The report did not identify the name or location of the user facility of the device in question.To date we have not been informed of this event directly from the user facility.Should we obtain additional information regarding the user facility or specific device subject of this event, a follow-up report would be filed with the results of our investigation.

• Brand Name: QUICK CATCH IN-LINE SUCTION POLYP TRAP
• Common Device Name: 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: 14748938
• Report Number: 1528319-2022-00034
• Device Sequence Number: 2382588
• Product Code: KDQ
• UDI-Device Identifier: 00724995184704
• UDI-Public: 00724995184704
• Combination Product (Y/N): N
• 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
• Type of Report: Initial
• Report Date (Section B): 06/20/2022

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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