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 Code	No Code Available (3191)
Date of Event	10/10/2018
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 an operation of thoraco/lobectomy it was double sealed and resected in.At this timing, there was no problem with the hemostasis and resection was completed and an end tone was heard.After the operation, the patient was taken to the intensive care unit (icu) and the blood pressure decreased after about 1-2 hours.As the result of confirming by computed tomography (ct), less than 500cc of bleeding was from the end segment of pa which was sealed.The reoperation was done by open surgery by piercing ligation and the patient also had blood transfusion.It was not bleeding from one part of the end segment, but from several parts.The used device was disposed and would not be returned.

• 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: 8039913
• Report Number: 1717344-2018-01451
• Device Sequence Number: 1421506
• Product Code: GEI
• UDI-Device Identifier: 10884521181588
• UDI-Public: 10884521181588
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141153
• 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): 11/05/2018

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: 10/10/2018
• Initial Report FDA Received Date: 11/05/2018
• 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: Life Threatening; Required Intervention