MAUDE Adverse Event Report: LINA MEDICAL POLSKA SP. Z.O.O LINA BIPOLAR LOOP

Model Number BL-160

Device Problem Device Handling Problem (3265)

Patient Problem No Information (3190)

Event Date 09/30/2013

Event Type  malfunction  

Event Description

Doctor ignited the bipolar loop and it began cutting.About 1/8 of the way through the cervix the loop broke at the electrode.

Manufacturer Narrative

Most possible reason of the loop break is bending of the wire in a way that it didn't stand the pressure and the heat at the same time.

• Brand Name: LINA BIPOLAR LOOP
• Type of Device: BIPOLAR LOOP
• Manufacturer (Section D): LINA MEDICAL POLSKA SP. Z.O.O; sady; tarnowo, podgorne 0000 ; PL 0000
• Manufacturer (Section G): LINA MEDICAL POLSKA SP. Z.O.O; ul.rolna 8; sady; tarnowo podgorne 0000 ; PL 0000
• Manufacturer Contact: anne klitgard ; formervangen 5; glostrup 00002-600 ; DA 00002600
• MDR Report Key: 3770331
• MDR Text Key: 16779859
• Report Number: 3007699067-2014-00003
• 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: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: BL-160
• Device Lot Number: 13111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1