MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB FT10; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VLFT10GEN

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

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

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(medical intervention: bacitracin ointment).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a procedure, they used the unit with a cautery electrode blades 6.5 and 2.75, and lighted breast retractor with wide wave guide.A dime-sized burn on the patient's left chest below surgical incision was noted.They applied bacitracin ointment to the site.

• Brand Name: VALLEYLAB FT10
• 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; voulder, CO 80301 ; 2034925563
• MDR Report Key: 10197396
• MDR Text Key: 196619407
• Report Number: 1717344-2020-00669
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521516328
• UDI-Public: 10884521516328
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VLFT10GEN
• Device Catalogue Number: VLFT10GEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2020
• Date Device Manufactured: 02/25/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 67 YR