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

Model Number LF2019

Device Problem Energy Output Problem (1431)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, during thyroidectomy, bleeding occurred after utilizing ligasure exact device.Regarsp alert was unknown and an end tone was heard.The surgeon controlled the bleeding with bipolar forceps.Post op apparently the patient had additional bleeding and needed to be taken back to the operating room (or).The representative told that it was apparently the second time in a few weeks that the surgeon had to take a patient back due to post op bleeding.

• 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: 11086951
• MDR Text Key: 224042127
• Report Number: 1717344-2020-01553
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521741096
• UDI-Public: 10884521741096
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: LF2019
• Device Catalogue Number: LF2019
• Device Lot Number: LF2019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2020
• 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): Other
• Patient Age: 33 YR
• Patient Weight: 145