MAUDE Adverse Event Report: US ENDOSCOPY LARIAT; SNARE

Model Number	00711119
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The distributor reported that during polypectomy's their lariat snare "twisted" and "did not cut" resulting in an injury.It is unknown what type of injury occurred or if medical treatment was sought or administered.
Additional Manufacturer Narrative
The type of report (g6) "15-day" was inadvertently selected in error on the initial report.A correction report is being filed to properly indicate a "30-day" type of report.

• Brand Name: LARIAT
• Common Device Name: SNARE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4404130648
• MDR Report Key: 20140516
• Report Number: 1528319-2024-00073
• Device Sequence Number: 15307958
• Product Code: FDI
• UDI-Device Identifier: 00724995182632
• UDI-Public: (01)00724995182632
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 09/04/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/28/2022
• 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