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

Model Number	E1450-6
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2018
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 procedure, when the electrode was activated, the tip produces a flame.Generator was used during the event.There was no patient injury.
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 procedure, when the electrode was activated, the tip produced a match size flame.This flame only occurred when the device was activated, so it was self extinguished.Generator was used during the event.Replaced with similar device and it worked fine which completed the procedure.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned electrode did not meet specification as received.Visual inspection found charring on the electrode tip.The reported condition could not be confirmed, but the electrode showed damage consistent with heat damage.Inspection noted that the electrode tip was charred and the coating was beginning to wear off.The device was correctly assembled.Activating the device can result in arcing if other conductive objects are nearby, particularly at a higher power setting.Combustion can occur under these circumstances particularly when an enriched oxygen or nitrous oxide environment is present.The investigation identified the probable root cause of the reported event to be the user activating the device in such a way that the device arced.The instructions for use (ifu) states, both oxygen and nitrous oxide support combustion.Watch for enriched oxygen and nitrous oxide atmospheres near the surgical site, especially during head and neck surgery.Enriched oxygen atmospheres may result in fires and burns to patients or surgical personnel.Do not exceed the maximum power limits as stated in the ifu.Exceeding these power limits may result in patient injury or product damage.If the electrode is damaged, discard it.Always use the lowest power setting to achieve the desired surgical effect.The maximum power settings are detailed in the instructions for use.Some surgeons may elect to buzz the hemostats during a surgical procedure.This practice is not recommended and the hazards of such a practice probably cannot be eliminated.To minimize the risk, when using coated electrodes, place the edge of the electrode against the hemostat or metal instrument to assure a good electrical pathway.Do not activate the generator until the accessory makes contact with the instrument.Additional measures to minimize the risk of performing this technique are listed in the electrosurgical generator users manuals.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EDGE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 8085513
• Report Number: 1717344-2018-01510
• Device Sequence Number: 1693856
• Product Code: GEI
• UDI-Device Identifier: 10884521713130
• UDI-Public: 10884521713130
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K955836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2019

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: 06/23/2023
• Device Model Number: E1450-6
• Device Catalogue Number: E1450-6
• Device Lot Number: 81750004X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 11/30/2018; 01/11/2019
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 12/27/2018; 02/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR