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

Model Number	LF5544
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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
According to the reporter, during laparoscopic sleeve gastrectomy procedure, the surgeon inserted the ligasure device through the trocar and when the instrument was visible on the video monitor, the surgeon noticed that the 'sleeve' on the end of the shaft of the device, looked as though it was loose and on the verge of detaching from the shaft.Therefore, he removed the instrument and did not use it.The suturing device was difficult to load.The surgeon then used another device to resolve the issue in order to complete the case.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: 8940429
• Report Number: 1717344-2019-01114
• Device Sequence Number: 19447531
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2019

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 Model Number: LF5544
• Device Catalogue Number: LF5544
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1