MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER LIGASURE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	LF1723
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Codes	Tissue Damage (2104); Blood Loss (2597)
Date of Event	10/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a thoracoscopic right upper large area resection (pa1+2c), at the first sealing, sealing was performed without ligation, at that time there was no problem, but major bleeding occurred from the same location after 5 minutes.The video was checked, the product was not dirty, and it was not tensioned.Dissection distance was enough, the product was used at the slightly root side of the center of the jaws.And after sealing, the same location was not touched at all.The sealing was a fast seal for about 1 second.When checking the video, it was noticed that both sides of the jaws were burned, but it seemed like it was not sealed only inside the jaw.There was tissue damage and tissue repair were necessary to stop the bleeding by fibrin sealant patch.More than 500 cc of bleeding occurred because of the issue, but no blood transfusion was required.There was no re-grasp alert, and there was a sealing tone and end tone.

• Brand Name: LIGASURE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 8058714
• Report Number: 1717344-2018-01469
• Device Sequence Number: 16842073
• Product Code: GEI
• UDI-Device Identifier: 10884521181588
• UDI-Public: 10884521181588
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2018

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 Model Number: LF1723
• Device Catalogue Number: LF1723
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 11/12/2018
• 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: Required Intervention