MAUDE Adverse Event Report: US ENDOSCOPY COINTIP; COINTIP SNARE

Model Number	00711110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via medwatch mw5186172 that during a patient procedure, the handle of their cointip snare broke.The procedure was completed successfully with another snare.No report of injury.
Additional Manufacturer Narrative
Investigation of the event is currently in progress.The device is being returned for evaluation.A follow-up report will be submitted when additional information becomes available.

• Brand Name: COINTIP
• Common Device Name: COINTIP SNARE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5976 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 25234525
• Report Number: 1528319-2026-00052
• Device Sequence Number: 21404944
• Product Code: FDI
• UDI-Device Identifier: 00724995194369
• UDI-Public: (01)00724995194369(11)250409(17)280409(10)12144228
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/20/2026

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: 00711110
• Device Catalogue Number: 00711110
• Device Lot Number: (10)12144228
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/20/2026
• Date Device Manufactured: 04/09/2025
• 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