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

Model Number	E1450-4
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used e1450 electrode was received, and an evaluation of the sample could not confirm a device issue.Visual inspection found part of the coating to have worn away and the electrode tip was slightly charred.Both of these observed conditions occur with usual activation of the device and are not defects.The electrode showed no signs of heat damage.Simulated use of the device confirmed that it functioned normally and within specifications.No flame or abnormal effects occurred.The instructions for use included with this device cautions users that sparking and heat are associated with electrosurgery and can be an ignition source.Measures in order to prevent any fire hazards are also provided.
Event or Problem Description
The customer reported that during a procedure, a flame occurred when the electrode tip came into contact with tissue and was activated.No patient injury resulted from the issue, and a new device was used to continue the procedure.

• 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: 6916465
• Report Number: 1717344-2017-05987
• Device Sequence Number: 16472015
• Product Code: GEI
• UDI-Device Identifier: 20884521036946
• UDI-Public: 20884521036946
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955836
• 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
• Report Date (Section B): 09/07/2017

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: 10/01/2020
• Device Model Number: E1450-4
• Device Catalogue Number: E1450-4
• Device Lot Number: 52740077X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1