MAUDE Adverse Event Report: US ENDOSCOPY ISNARE; ISNARE SYSTEM-LARIAT SNARE

Model Number	00711084
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via medwatch (b)(4) that the isnare handle "broke in half" and the stent was unable to deploy.Another device was utilized for the patient procedure.No report of injury.
Additional Manufacturer Narrative
Steris requested the isnare subject of the reported event be returned for evaluation.The device history record was reviewed for the subject lot and no abnormalities were noted.A complaint review was performed and confirmed the event to be isolated for the subject lot.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The isnare system-lariat snare subject of the reported event was returned for evaluation.Evaluation results found the hypo tube in the handle assembly to be bent in a "v" shape.There was a significant curve in the sheath below the handle, the distal end of the device was curved, and the hypo tube in the needle handle assembly was bent.The damage found on the device is indicative of the user 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 which can cause the device to not operate as intended.The instructions for use states, "prior to clinical use, inspect and familiarize yourself with the device.If there is evidence of damage (i.E.Deformed or bent snare or needle, inoperable handle, damaged packaging), do not use this product and contact your local product specialist.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." steris made multiple attempts offering in-service training, however the user facility did not respond.No additional issues have been reported.

• Brand Name: ISNARE
• Common Device Name: ISNARE SYSTEM-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: 21767025
• Report Number: 1528319-2025-00027
• Device Sequence Number: 12909211
• Product Code: FDI
• UDI-Device Identifier: 00724995180782
• UDI-Public: (01)00724995180782(11)240613(17)270613(10)10584069
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/03/2025

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: 00711084
• Device Catalogue Number: 00711084
• Device Lot Number: (10)10584069
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• 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