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

Model Number	E2515H
Medical Device Problem Codes	Fire (1245); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the passage of hemostasia of the cruent area of the resection of basocellular carcinoma, a complication occurred in which the patient had burn in the nasal tip, nasogenian groove, nasal wings, upper skin lip and medial edges of the cheeks.The burn was immediately washed with 1000 cc of saline solution and occlusive cutting with micropore, put medical adhesive and pain modulation with acetaminophen.It was also noted that during the surgical procedure, a surface second degree burn complication occurred because the oxygen interactions with the electrocautery.There was a fire under the patient's facemask.
Event or Problem Description
According to the reporter, during the passage of hemostasia of the cruent area of the resection of basocellular carcinoma, a complication occurred in which the patient had burn in the nasal tip, nasogenian groove, nasal wings, upper skin lip and medial edges of the cheeks.The burn was immediately washed with 1000 cc of saline solution and occlusive cutting with micropore, put medical adhesive and pain modulation with acetaminophen.It was also noted that during the surgical procedure, a surface second degree burn complication occurred because the oxygen interactions with the electrocautery.The two devices were used in the same patient and the same surgery.They do not know but the patient suffered a burn and the idea was to know what practice was done wrong or if the devices failed.There was a fire under the patient's facemask.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13366165
• Report Number: 1717344-2022-00101
• Device Sequence Number: 19831354
• Product Code: GEI
• UDI-Device Identifier: 10884524000046
• UDI-Public: 10884524000046
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K813071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: E2515H
• Device Catalogue Number: E2515H
• Device Lot Number: 212770250R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 04/22/2022
• Date Device Manufactured: 10/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 54 KG