MAUDE Adverse Event Report: LINA MEDICAL LINA BIPOLAR LOOP; COAGULATOR-CUTTER, ENDOSCOPIC

Model Number	BL-200
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Initial attempt at amputating the uterine body from the cervix with a lina loop resulted in the lina loop wire breaking and not cutting.All parts of the lina loop were removed from the body and no injury resulted.

• Brand Name: LINA BIPOLAR LOOP
• Common Device Name: COAGULATOR-CUTTER, ENDOSCOPIC
• Manufacturer (Section D): LINA MEDICAL; 2500 bee cave road; bldg 1, suite 300; austin TX 78746
• MDR Report Key: 8955185
• Report Number: 8955185
• Device Sequence Number: 328615
• Product Code: HIN
• UDI-Device Identifier: 05708265004621
• UDI-Public: (01)05708265004621(17)211127(11)181203(10)1849006
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/12/2019
• Report Date (Section F): 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: BL-200
• Device Catalogue Number: BL-200
• Device Lot Number: 1849006
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/03/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2019
• 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: 08/12/2019