MAUDE Adverse Event Report: US ENDOSCOPY LARIAT; LARIAT SNARE

Model Number	00711119
Medical Device Problem Codes	Failure to Cut (2587); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris has requested the return of the devices of the reported event for further evaluation.The instructions for use states, "advancing 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 actuating the device when the handle is at an acute angle in relation to the sheath." a complaint review confirmed this to be an isolated event for the subject lot.A follow-up mdr will be submitted should additional information become available.
Event or Problem Description
The user facility reported during a patient procedure that three of their lariat snares got caught while cutting polyps.This resulted with a procedure delay.The procedure was completed successfully using a different snare.No report of injury.
Additional Manufacturer Narrative
The devices subject of the reported event were returned for evaluation.Two of the used devices were cut by the user and could not be tested.The third device was tested and found to be working to specification.The reported issue could not be duplicated; no device malfunction was identified.Therefore, a cause of the reported event could not be determined.Steris offered in-service on the proper use and operation of the lariat snare.However, the user facility declined.No additional issues have been reported.

• Brand Name: LARIAT
• Common Device Name: LARIAT SNARE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor 44060 ; 4404130648
• MDR Report Key: 21653558
• Report Number: 1528319-2025-00020
• Device Sequence Number: 15309625
• Product Code: FDI
• UDI-Device Identifier: 00724995182632
• UDI-Public: (01)00724995182632(17)271219(11)241219(10)11156102
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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: 00711119
• Device Catalogue Number: 00711119
• Device Lot Number: (10)11156102(10)11652880
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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