MAUDE Adverse Event Report: LINA MEDICAL APS LINA BIPOLAR LOOP

Model Number	BL-200
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: LINA BIPOLAR LOOP
• Manufacturer (Section D): LINA MEDICAL APS; formenwangen 5; glostrup, 2600 ; DA 2600
• MDR Report Key: 9138244
• Report Number: 3007699067-2019-00004
• Device Sequence Number: 419334
• Product Code: HIN
• UDI-Device Identifier: 05708265004621
• UDI-Public: (01)05708265004621(17)211127(11)181203(10)1849006
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/01/2019

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR