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

Model Number	00711084
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event was returned to us endoscopy for evaluation, which confirmed a snare wire break near the connection to the control cable.Based on us endoscopy's evaluation, excessive force being applied by user facility personnel may have contributed to the snare wire break.The device history record was reviewed and confirmed the device lot was manufactured to specification.There have been no other complaints associated with this lot.A review of past complaints for this device indicates this to be an isolated event.Statements in the instructions for use include: "to avoid patient injury, do not apply excessive force to the snare while resecting tissue.The following conditions may not allow the isnare system - 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." a us endoscopy representative has provided in-service training regarding use of the isnare system - lariat system to the facility.No additional issues have been reported.
Event or Problem Description
The user facility reported that the snare loop of their isnare system - lariat snare detached during a patient procedure.The loop was retrieved with a forceps device and the procedure was completed successfully with a second isnare system - lariat snare.There was no report of harm to the patient or user.

• Brand Name: ISNARE SYSTEM - LARIAT SNARE
• Common Device Name: ISNARE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 9155761
• Report Number: 1528319-2019-00037
• Device Sequence Number: 11302137
• Product Code: FDI
• UDI-Device Identifier: 00816765012741
• UDI-Public: (01)00816765012741
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K152035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2019

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 Expiration Date: 07/14/2022
• Device Model Number: 00711084
• Device Catalogue Number: 00711084
• Device Lot Number: 1909875
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1