MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. iSnare; iSnare system ¿ Lariat snare

Model Number	00711084
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure, the needle to their isnare system ¿ lariat snare was getting stuck in the out position after injection, even when the luer lock handle was depressed.User facility personnel utilized another device, and the procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
The isnare system ¿ lariat snare is being returned to steris for evaluation.Investigation of the event is currently in progress.A follow-up report will be submitted when additional information becomes available.

• Brand Name: iSnare
• Common Device Name: iSnare system ¿ Lariat snare
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; +1(440)259-7401
• MDR Report Key: 50479760
• Report Number: 1528319-2026-00102
• Device Sequence Number: 21383310
• Product Code: FBK
• UDI-Device Identifier: 00724995180782
• UDI-Public: (01)00724995180782(11)250821(17)280821(10)12682278
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 08/27/2026

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: 00711084
• Device Catalogue Number: 00711084
• Device Lot Number: (10)12682278
• 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: 07/29/2026
• Initial Report FDA Received Date: 08/27/2026
• Date Device Manufactured: 08/21/2025
• 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