MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. LARIAT SNARE

Model Number	00711119
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event was returned and evaluated; it was found that the hypo tube in the handle assembly of the lariat snare was bent in two places.The damage found in the hypo tube is indicative of the user applying too much force or speed while trying to advance the handle to open the device.The instructions for use (ifu 731965) provided with the device gives the following information that may cause the device to not 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, and no abnormalities were noted.The complaint log was reviewed, and this is an isolated event.Steris endoscopy offered in-service training on the proper use of the lariat snare; however, the user facility declined.No additional issues have been reported.
Event or Problem Description
((b)(4)) that their lariat snare broke during a patient procedure.No report of injury.

• Brand Name: LARIAT SNARE
• Common Device Name: LARIAT SNARE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 15730442
• Report Number: 1528319-2022-00057
• Device Sequence Number: 11512016
• Product Code: FDI
• UDI-Device Identifier: 00724995182632
• UDI-Public: 00724995182632
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 11/03/2022

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: 2109972
• 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: 10/07/2022
• Initial Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2021
• 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