MAUDE Adverse Event Report: LINA MEDICAL APS LINA BIPOLAR LOOP

Model Number BL-200

Device Problems Break (1069); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

All in all information about device malfunction we received on 10th september 2019 from (b)(6) of emergo.In medwatch report received from emergo, initial reporter stated that device is available for evaluation.Unfortunately we haven't received the product back so we haven't performed investigation.Furthermore out distributor tried to contact with initial reporter a few times and it was unable to reach her.Furthermore we haven't received any information from hospital about this event till 10th september from emegro.Based on that product in not available for investigation, and we haven't received any pictures and movies we are not able to provide the reason of malfunction.However we reviewed dhr documentation nad no non-conformances were identified during manufacturing process.To sum up no corrective action required.

Event Description

Description provided by initial reporter: "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" date of event: (b)(6) 2019.

• Brand Name: LINA BIPOLAR LOOP
• Type of Device: LINA BIPOLAR LOOP
• Manufacturer (Section D): LINA MEDICAL APS; formenwangen 5; glostrup, 2600 ; DA 2600
• Manufacturer (Section G): MONIKA LEWANDOWSKA; rolna 8a; sady, 62-08 0; PL 62-080
• Manufacturer Contact: monika lewandowska ; formenvangen 5; glostrup, 2600 ; DA 2600
• MDR Report Key: 9138244
• MDR Text Key: 219163274
• Report Number: 3007699067-2019-00004
• Device Sequence Number: 1
• Product Code: HIN
• UDI-Device Identifier: 05708265004621
• UDI-Public: (01)05708265004621(17)211127(11)181203(10)1849006
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/27/2021
• Device Model Number: BL-200
• Device Catalogue Number: BL-200
• Device Lot Number: 1849006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR