MAUDE Adverse Event Report: US ENDOSCOPY ETRAP; ETRAP POLYP TRAP

Model Number	00711099
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via vigilance report that an insect was found inside of etrap polyp trap packaging when opened.No report of injury.
Additional Manufacturer Narrative
The etrap polyp trap subject of the reported event was discarded by the user facility and is not available for return.The device history record for the unit was reviewed and confirmed the unit was manufactured according to specifications.This is an isolated event.The instructions for use (ifu 731200) gives the user the following information "inspect the package and device for shipping or handling damage, i.E.Cracked clear vessel, bent, misshapen, or missing specimen retrieval strainer(s), cracked, torn, or missing connection tube.If damage is evident do not use these devices, save them for return, and contact your local product specialist." no additional issues have been reported.

• Brand Name: ETRAP
• Common Device Name: ETRAP POLYP TRAP
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4404130648
• MDR Report Key: 20317032
• Report Number: 1528319-2024-00078
• Device Sequence Number: 7613316
• Product Code: KDQ
• UDI-Device Identifier: 00724995184728
• UDI-Public: (01)00724995184728(11)20240208(17)20270208(10)8489833
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 09/26/2024

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: 00711099
• Device Catalogue Number: 00711099
• Device Lot Number: (10)8489833
• 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: 09/11/2024
• Initial Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2024
• 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