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 Patient Involvement (2645)
Date of Event	10/29/2018
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, prior to use, when they used the pencil the gauze ignited.There was a presence of flame, but disappeared immediately.Both of the device was change to continue.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary this report is based on information provided by post market vigilance investigation personnel.One device was received for evaluation.The returned product met specification as received.Visual inspection found eschar on the tip of both of the devices and some charring.No components were missing from either device.No manufacturing defects were identified during the product investigation.Visual inspection found the electrode to have been manufactured correctly.No components were missing from the device.The tips of both electrodes were slightly 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.The electrode passed hipot testing.The investigation found the device to function normally and within specifications.The ifu states, the sparking and heating associated with electrosugery can provide an ignition source.Observe fire precautions at all times: when using electrosurgery 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: 8114750
• Report Number: 1717344-2018-01558
• Device Sequence Number: 1692091
• Product Code: GEI
• UDI-Device Identifier: 10884521713185
• UDI-Public: 10884521713185
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K981916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

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: 01/30/2023
• Device Model Number: E1455-4
• Device Catalogue Number: E1455-4
• Device Lot Number: 80260108X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1