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	01/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a colonoscopy procedure i removed a small polyp with a cold snare device.The polyp was removed per normal and site looked good, however when i removed (pulled) snare from the scope and with inspection i noticed the snare was open.The snare lost open and close functionality.Like maybe a like broke or snapped.The doctor and rn were aware of incident and procedure was completed without and further issue.

• Brand Name: EXACTO
• Common Device Name: SNARE, NON-ELECTRICAL
• Manufacturer (Section D): US ENDOSCOPY; 5960 heilsey road; mentor OH 44060
• MDR Report Key: 16378119
• Report Number: 16378119
• Device Sequence Number: 12282365
• Product Code: FGX
• UDI-Device Identifier: 00724995182618
• UDI-Public: (01)00724995182618
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/09/2023
• Report Date (Section F): 02/09/2023

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
• Device Model Number: 00711115
• Device Catalogue Number: 00711115
• Device Lot Number: 471831
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/15/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2023
• 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: 02/09/2023