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

Model Number	00711084
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event was returned for evaluation.The needle had disconnected from the internal peek so when it was released the needle stayed deployed.The device history record was reviewed, and no abnormalities were noted.There have been no other complaints associated with this lot.The instructions for use (ifu (b)(4) gives the following instruction to the user; "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." no additional issues have been reported.
Event or Problem Description
The user facility reported that during a procedure while using their lariat snare the needle would not retract.No injury reported.

• Brand Name: ISNARE SYSTEM-LARIAT SNARE
• Common Device Name: 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: 15828077
• Report Number: 1528319-2022-00059
• Device Sequence Number: 12300919
• Product Code: FDI
• UDI-Device Identifier: 00724995180782
• UDI-Public: 00724995180782
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/18/2022

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: 2207192
• 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: 10/21/2022
• Initial Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2022
• 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