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

Model Number LF2019

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

Patient Problems Burn(s) (1757); Tissue Damage (2104); No Code Available (3191)

Event Date 07/14/2020

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.The picture showed the device and the caricature of the shape of the reported burn.A comprehensive examination could not be performed, because the returned sample was not received in a state that allowed full functional or visual assessment.It was reported that use of device resulted in a burn.The reported issue could not be confirmed.The most likely root cause could not be established from the information available.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a bilateral mastectomy procedure, when the surgeon was cauterizing the internal breast tissue with the ligasure, the patient skin was burned with the exact same shape of the ligasure (where it articulates but is insulated - grey meets white color).The burn scar was approximately 1cm high and 2cm wide.Surgeon corrected the scar by dissecting the effected tissue, suturing and providing good cosmetic appearance for the patient intraoperative at the time of the burn.

• 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: 10374749
• MDR Text Key: 201908393
• Report Number: 1717344-2020-00844
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521741096
• UDI-Public: 10884521741096
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K173281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF2019
• Device Catalogue Number: LF2019
• Device Lot Number: 00750103X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention