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

Model Number	LF5544
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a vertical sleeve gastrectomy and hernia repair, half of the plastic protector of the ligasure tip was off the handpiece.The piece was viewed inside the patient with the laparoscopic camera and removed.

• Brand Name: LIGASURE ADVANCE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 9161225
• Report Number: 1717344-2019-01263
• Device Sequence Number: 1776657
• Product Code: GEI
• UDI-Device Identifier: 10884524002279
• UDI-Public: 10884524002279
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K063195
• 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): 10/07/2019

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: Health Professional
• Device Expiration Date: 11/15/2022
• Device Model Number: LF5544
• Device Catalogue Number: LF5544
• Device Lot Number: 73180234X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1