MAUDE Adverse Event Report: LINA MEDICAL APS LINA BIPOLAR LOOP, LARGE

Model Number BL-200

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturer is waiting for the device to be returned so that he can perform the examination.

Event Description

"allegedly, the ceramic tip came off on 2ea bl-200 during surgery.".

• Brand Name: LINA BIPOLAR LOOP, LARGE
• Type of Device: LINA BIPOLAR LOOP, LARGE
• Manufacturer (Section D): LINA MEDICAL APS; formervangen 5; glostrup, DK-26 00; DA DK-2600
• Manufacturer (Section G): LINA MEDICAL POLSKA SP. Z O.O.; 8a rolna, sady; tarnowo podgórne, 62-08 0; PL 62-080
• Manufacturer Contact: joanna mazur ; formervangen 5; glostrup, DK-26-00 ; DA DK-2600
• MDR Report Key: 9882045
• MDR Text Key: 202724253
• Report Number: 3007699067-2016-00003
• Device Sequence Number: 1
• Product Code: HIN
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/12/2016

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
• Device Operator: No Information
• Device Model Number: BL-200
• Device Catalogue Number: BL-200
• Device Lot Number: 1541042
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/10/2016
• Initial Date FDA Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1