MAUDE Adverse Event Report: LINA MEDICAL APS LINA GOLD LOOP; LINA GOLD LOOP, LARGE, PRODUCT CODE: KNF

Model Number	EL-200-8
Health Effect - Clinical Code	Perforation (2001)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The defective device has not been returned to manufacturer.Information from distributor is that they have not been able to retrieve the product yet.The nurse said that it was either thrown away or passed on to risk management, who has not responded to our inquiries.So we are still waiting for the final decision.
Event or Problem Description
Dr.(b)(6) was using the lina gold loop and the patients right external iliac artery was nicked.Via 2nd hand info, a nurse said that the loop broke, but it's unclear what specifically was meant by the term "broke".The nurse did not know the generator type, nor the generator settings.When asked if the uterine manipulator was possibly left in place, the nurse did not know, but said the surgeon had experience using the loop previously.
Event or Problem Description
Dr.Was using the lina gold loop and the patients right external iliac artery was nicked.

• Brand Name: LINA GOLD LOOP
• Common Device Name: LINA GOLD LOOP, LARGE, PRODUCT CODE: KNF
• Manufacturer (Section D): LINA MEDICAL APS; formervangen 5; glostrup,, denmark DK260 0; DA DK2600
• MDR Report Key: 7808256
• Report Number: 3007699067-2018-00002
• Device Sequence Number: 19282118
• Product Code: KNF
• UDI-Device Identifier: 05708265001354
• UDI-Public: 05708265001354
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/11/2019
• Device Model Number: EL-200-8
• Device Catalogue Number: EL-200-8
• Device Lot Number: 1642011
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/20/2018
• Device Age: 2 YR
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other