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

Model Number	LF1644
Medical Device Problem Code	Energy Output To Patient Tissue Incorrect (1209)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	04/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The incident sample was requested but to date has not been received for evaluation.If the sample or additional information pertinent to the incident is obtained, a follow-up report will be submitted.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that after a procedure where the device was used for sealing gastric vessels, bleeding occurred from one of the seal sites.The procedure was on (b)(6) 2017 and the issue required a reoperation on (b)(6) 2017.Over 500cc¿s of blood loss is estimated, but no transfusion was performed.The patient is currently within the hospital.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6553123
• Report Number: 1717344-2017-05299
• Device Sequence Number: 13705568
• Product Code: GEI
• UDI-Device Identifier: 20884521210865
• UDI-Public: 20884521210865
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K142929
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2017

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: 12/18/2021
• Device Model Number: LF1644
• Device Catalogue Number: LF1644
• Device Lot Number: 63540156X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2017
• Supplement Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 05/08/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR