MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. EXACTO COLD SNARE

Model Number	00711115
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure their exacto cold snare failed to cut through a cecal polyp in its entirety.The procedure was considered not completed, with a recommendation for the patient to follow-up in six months to a year.No report of injury.
Additional Manufacturer Narrative
The exacto cold snare subject of the reported event was returned to steris for evaluation.The quality systems specialist tested the function of the device and the cutting ability.The device deployed and retracted without issue in multiple configurations.The device was able to cut multiple simulated polyps of different sizes without issue.Based on the review of the device, the cause of the reported issue could not be determined.The exacto cold snare instructions for use states that the following conditions may not allow the device to perform properly: "prior to clinical use, inspect and familiarize yourself with the device.If there is evidence of damage, do not use this product and contact your local product specialist.Attempting to advance the handle to the open position with too much speed or force, attempting to pass or open the device in an extremely articulated endoscope, attempting to actuate the device in an extremely coiled position, and/or, attempting to actuate the device when the handle is at an acute angle in relation to the sheath." the device history record was reviewed, and no abnormalities were noted.There have been no other complaints associated with this lot.No additional issues have been reported.

• Brand Name: EXACTO COLD SNARE
• Common Device Name: SNARE
• 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: 17328928
• Report Number: 1528319-2023-00029
• Device Sequence Number: 6347505
• Product Code: FGX
• UDI-Device Identifier: 00724995182618
• UDI-Public: 00724995182618
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/14/2023

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: 00711115
• Device Catalogue Number: 00711115
• Device Lot Number: 5722124
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2023
• 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