MAUDE Adverse Event Report: US ENDOSCOPY ROTH NET; SNARE, FLEXIBLE

Model Number	00711057
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During esophagogastroduodenoscopy (egd) for foreign body removal, the physician was attempting to remove the foreign body specimen when the netting broke away from the looping.Event was rectified, however on second attempt the same occurred again.

• Brand Name: ROTH NET
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 7929365
• Report Number: 7929365
• Device Sequence Number: 2270102
• Product Code: FDI
• UDI-Device Identifier: 00816765010891
• UDI-Public: (01)00816765010891
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/27/2018
• Report Date (Section F): 09/27/2018

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: 00711057
• Device Catalogue Number: 00711057
• Device Lot Number: 1606764
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/27/2018