MAUDE Adverse Event Report: US ENDOSCOPY LARIAT; SNARE

Model Number	00711119
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation into the reported event is in progress; a follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure their lariat snare fell apart.There was a "flash" observed, and the cautery was stopped.The procedure was completed successfully using a different hot snare.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event was returned to steris for evaluation; the evaluation revealed charred marks on the loop of the snare, and it was confirmed that the device was broken.In addition, there were multiple kinks found in the drive cable, and the hypotube was bent in the handle assembly.Based on the evaluation of the device, the reported event could not be duplicated.Steris offered in-service training on the proper use and operation of the lariat snare; however, the user facility declined.The instructions for use states, "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.The following conditions may not allow the lariat® snare device to function properly: 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." the device history record was reviewed for the subject lot and confirmed the lot was manufactured according to specifications; no abnormalities were noted.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: LARIAT
• Common Device Name: 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: 22118040
• Report Number: 1528319-2025-00045
• Device Sequence Number: 7062872
• Product Code: FDI
• UDI-Device Identifier: 00724995182632
• UDI-Public: (01)00724995182632(11)240926(17)270926(10)11084997
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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: 00711119
• Device Catalogue Number: 00711119
• Device Lot Number: (10)11084997
• 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: 05/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2024
• 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