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

Model Number	E1455-4
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2019
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 a laparotomy, the surgeon was using a pencil with the extended 4 inch guarded tips.Immediately after using it inside the wound, while the surgeon had the tip above the wound, it ignited a flame.They immediately changed the hand piece and machine.They also switched the generator and opened new pad and pencil to complete the procedure.The patient was not burned, the surgeon was not burned.There was no further information available and good faith attempts have been made.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.Visual inspection found eschar on the tip of the device and charring.The polytetrafluoroethylene (ptfe) insulator had softened and slightly deformed.Visual inspection found the electrode to have been manufactured correctly.The ptfe insulator had softened and slightly deformed.The tip of the electrode was discolored where the coating had begun to erode.The purpose of the coating is to limit the tissue from sticking to the electrode.The coating erodes as the electrode is activated.The tip of the electrode also discolors when activated and used on tissue.This effect is a normal part of electro surgery and is not considered a defect.Significant eschar buildup at the tip could lead to overheating and conceivably device fire.The investigation identified the root cause of the damage to the electrode to be eschar build up on the electrode tip leading to excessive heating.The instructions for use(ifu) states, the sparking and heating associated with electrosurgery can provide an ignition source.Observe fire precautions at all times: when using electro surgery in the same room with gases or flammable substances, prevent pooling of fluids and the accumulation of gases under surgical drapes or near the surgical site.Tissue buildup (eschar) on the tip of an active electrode poses a fire hazard, especially in oxygen-enriched environments, such as in throat or mouth procedures.Eschar plus high oxygen may create embers.Keep the electrode clean and free of all debris.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: 8452515
• Report Number: 1717344-2019-00401
• Device Sequence Number: 14144663
• Product Code: GEI
• UDI-Device Identifier: 10884521713185
• UDI-Public: 10884521713185
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K981916
• 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
• Report Date (Section B): 06/11/2019

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: 09/08/2023
• Device Model Number: E1455-4
• Device Catalogue Number: E1455-4
• Device Lot Number: 82490170X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Initial Date Received by Manufacturer: 03/02/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR