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

Model Number	LF1744
Medical Device Problem Code	Energy Output To Patient Tissue Incorrect (1209)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	01/17/2018
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
The customer reported that during a bariatric sleeve procedure, the device did not seal.When sealing vessels, the surgeon heard an end tone and released the device, but the tissue was not sealed and bleeding resulted.Surgical intervention was required to prevent further bleeding by using manual clips and sutures in order to ligate the vessels.The device was removed and pressure applied.The vessels were ligated but took thirty minutes due to the bleeding.Blood loss was more than 500cc, however no transfusion was required.Ft10 generator was used during the event.

• 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: 7295233
• Report Number: 1717344-2018-00266
• Device Sequence Number: 1354888
• Product Code: GEI
• UDI-Device Identifier: 10884521181564
• UDI-Public: 10884521181564
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K141153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2018

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 Expiration Date: 05/22/2022
• Device Model Number: LF1744
• Device Catalogue Number: LF1744
• Device Lot Number: 71390168X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 02/25/2018
• 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