MAUDE Adverse Event Report: US ENDOSCOPY COINTIP; SNARE

Model Number	00711110
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the user facility's contact information was blank in the received medwatch, steris was unable to obtain additional information regarding the report event.Udi related data clarification - the lot/serial number is unknown; therefore, the applicable production identifiers were not included in the mdr.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch mw5184579 that "the sheath of the snare twisted when in use and was unable to cut the polyp off".No report of injury.

• Brand Name: COINTIP
• Common Device Name: 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: 25056812
• Report Number: 1528319-2026-00044
• Device Sequence Number: 10101104
• Product Code: FDI
• UDI-Device Identifier: 00724995194369
• UDI-Public: (01)00724995194369
• Combination Product (Y/N): N
• 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): 05/01/2026

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: 00711110
• Device Catalogue Number: 00711110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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