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

Model Number	LF5544
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
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
According to the reporter, during procedure, the device was working fine at the start, advanced at the same time and stopped working and remained locked.It was stuck at firing position.There was no patient injury.

• 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: 9207301
• Report Number: 1717344-2019-01367
• Device Sequence Number: 14217390
• Product Code: GEI
• UDI-Device Identifier: 10884524002279
• UDI-Public: 10884524002279
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K063195
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2019

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: 01/17/2023
• Device Model Number: LF5544
• Device Catalogue Number: LF5544
• Device Lot Number: 80180169X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR