MAUDE Adverse Event Report: LINA MEDICAL APS LINA BIPOLAR LOOP; LINA BIPOLAR LOOP, SMALL

Model Number	BL-160
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The defective devices has not been returned to manufacturer.
Event or Problem Description
Allegedly, 2ea bl-160 broke during surgery.

• Brand Name: LINA BIPOLAR LOOP
• Common Device Name: LINA BIPOLAR LOOP, SMALL
• Manufacturer (Section D): LINA MEDICAL APS; formervangen 5; denmark, glostrup DK260 0; DA DK2600
• MDR Report Key: 7937740
• Report Number: 3007699067-2018-00001
• Device Sequence Number: 13685714
• Product Code: HIN
• UDI-Device Identifier: 05708265004607
• UDI-Public: 05708265004607
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130305
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/05/2018
• Report Date (Section F): 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2019
• Device Model Number: BL-160
• Device Catalogue Number: BL-160
• Device Lot Number: 14351
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/20/2017
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0
• Date Report Sent to FDA: 04/04/2017