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

Model Number LF5644

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 06/29/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, post operatively, there was nothing unusual about the case, and the surgeon was not sure if it was a device issue, a stapler issue, or even a tissue handling issue.The report was filed to note the severity of the event and the requirement to bring the patient back to surgery.Post op bleed - came back to the operating room approximately 9 hours post operation.Hemorrhagic shock.Gave 5 units of blood and 4 units of fresh frozen plasma (ffp).Patient was sent home four days post op.Included 2 days in intensive care unit (icu).Laparoscopy was performed with evacuation of blood clots.No active bleeding found.Location was somewhere around greater curvature of stomach.Spleen, liver, and trocar sites were inspected, and no problems found.Patient is doing fine now, with no issues.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 10337409
• MDR Text Key: 200759247
• Report Number: 1717344-2020-00796
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521521742
• UDI-Public: 10884521521742
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161804
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF5644
• Device Catalogue Number: LF5644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention