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

Model Number FORCEFXC

Device Problems Fire (1245); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tissue Damage (2104); Skin Tears (2516); Partial thickness (Second Degree) Burn (2694)

Event Date 07/01/2020

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 debulking of oral flap for excision of the left chin basal cell carcinoma, a fire started around the mouth, nose, and right eye of the patient during the middle of the procedure, eye mask was removed immediately and fire was doused with sterile water, anesthesia turned off the nasal canula until it was put out.Fire lasted less than 2 seconds.Patient had a burn marks (superficial second degree burns) on the right cheek and across the bridge of the nose and some skin tear of right forehead due to trauma from removing goggles.Patient's eyes undamaged.Patient skin very sensitive.Bacitracin ointment and dermabond applied on the right forehead.Patient later discharged.

Event Description

According to the reporter, during a debulking of oral flap for excision of the left chin basal cell carcinoma, a fire started around the mouth, nose, and right eye of the patient during the middle of the procedure, eye mask was removed immediately and fire was doused with sterile water, anesthesia turned off the nasal canula until it was put out.Fire lasted less than 2 seconds.A competitor handpiece was used and associated device was a generator.Patient had a burn marks (superficial second degree burns) on the right cheek and across the bridge of the nose and some skin tear of right forehead due to trauma from removing googles.Patient's eyes undamaged.Patient skin was very sensitive.Bacitracin ointment and dermabond were applied on the right forehead.Patient was later discharged.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: FORCE FX
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 10746274
• MDR Text Key: 213379767
• Report Number: 1717344-2020-01305
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884524002613
• UDI-Public: 10884524002613
• Combination Product (y/n): N
• PMA/PMN Number: K944602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FORCEFXC
• Device Catalogue Number: FORCEFXC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 91 YR