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

Model Number LF2019

Device Problems Device Stops Intermittently (1599); Flare or Flash (2942)

Patient Problem Burn(s) (1757)

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during a procedure, the bottom outside the jaw burned the patient¿s neck.The sizes of the burn were v shaped and measured approximately 2-5 millimeters and a starlight shaped line with a measurement of 3-4 millimeters.The device was activated intermittently before the burn happened and the nurse applied bandage to cover the burn.

Manufacturer Narrative

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

• Brand Name: LIGASURE EXACT
• 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: 7654560
• MDR Text Key: 112861638
• Report Number: 1717344-2018-00881
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2020
• Device Model Number: LF2019
• Device Catalogue Number: LF2019
• Device Lot Number: 80020248X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2018
• Initial Date FDA Received: 07/02/2018
• Supplement Dates Manufacturer Received: 10/22/2018
• Supplement Dates FDA Received: 11/14/2018
• Date Device Manufactured: 01/09/2018
• 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 Age: 43 YR
• Patient Weight: 47