MAUDE Adverse Event Report: US ENDOSCOPY LARIAT; SNARE, FLEXIBLE

Model Number	00711119
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medical device broke while being used during colonoscopy - no injury to patient.

• Brand Name: LARIAT
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 15592613
• Report Number: 15592613
• Device Sequence Number: 2328309
• Product Code: FDI
• UDI-Device Identifier: 00724995182632
• UDI-Public: (01)00724995182632(17)240913(11)210914(10)2109972
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2022
• Report Date (Section F): 09/20/2022

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: 00711119
• Device Catalogue Number: 00711119
• Device Lot Number: 2109972
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 09/20/2022