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

Model Number BL-160

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2017

Event Type  malfunction  

Manufacturer Narrative

The defective devices has not been returned to manufacturer.

Event Description

Allegedly, 2ea bl-160 broke during surgery.

• Brand Name: LINA BIPOLAR LOOP
• Type of Device: LINA BIPOLAR LOOP, SMALL
• Manufacturer (Section D): LINA MEDICAL APS; formervangen 5; denmark, glostrup DK260 0; DA DK2600
• Manufacturer (Section G): LINA MEDICAL POLSKA SP. Z O.O.; rolna 8a; sady; tarnowo podgórne, 62-08 0; PL 62-080
• Manufacturer Contact: monika lewandowska ; formervangen 5; glostrup, DK260-0 ; DA DK2600
• MDR Report Key: 7937740
• MDR Text Key: 123518262
• Report Number: 3007699067-2018-00001
• Device Sequence Number: 1
• Product Code: HIN
• UDI-Device Identifier: 05708265004607
• UDI-Public: 05708265004607
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130305
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/04/2017,10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2017
• Distributor Facility Aware Date: 03/20/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 0