MAUDE Adverse Event Report: US ENDOSCOPY EXACTO; SNARE, NON-ELECTRICAL

Model Number	00711115
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Exacto cold snare would not completely come out of the device.

• Brand Name: EXACTO
• Common Device Name: SNARE, NON-ELECTRICAL
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 21630663
• Report Number: 21630663
• Device Sequence Number: 12828446
• Product Code: FGX
• UDI-Device Identifier: 00724995182618
• UDI-Public: (01)00724995182618(17)271111(11)241111(10)11296004
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2025
• Report Date (Section F): 03/04/2025

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
• Device Model Number: 00711115
• Device Catalogue Number: 00711115
• Device Lot Number: 11296004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/04/2025