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

Model Number LF1212

Device Problem Energy Output Problem (1431)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This product is not sold in us and is 510(k) exempt.This report is associated to a similar product sold in the us with 510(k) number k102470.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during thyroidectomy, after a good seal, there was light bleeding of the vessel which was about 50 ml with the unit and with the handpiece.The doctor stated that the patient was heparinized.Same generator and handpiece was used to complete the procedure.There was no patient injury.

• 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: 9997862
• MDR Text Key: 191136092
• Report Number: 1717344-2020-00472
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF1212
• Device Catalogue Number: LF1212
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2020
• 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