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

Model Number	E2515H-GNSB
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the product was not returned; however, a picture was provided by the customer for analysis.The product in the picture met specification.The picture showed the electrode tip was blackened.The reported condition was not confirmed.Visual inspection found no defects.No defects were detected with the device.The customer is advised to return the incident device so a complete evaluation can be performed.The investigation could not determine the root cause of the customer's report.The instructions for use (ifu) warns: the sparking and heating associated with electrosurgery 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.
Event or Problem Description
According to the reporter, the tip of the device caught fire size of a birthday candle flame.There was no patient injury.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 9241499
• Report Number: 1717344-2019-01417
• Device Sequence Number: 11156248
• Product Code: GEI
• UDI-Device Identifier: 10884524003634
• UDI-Public: 10884524003634
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K813071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2019

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 Model Number: E2515H-GNSB
• Device Catalogue Number: E2515H-GNSB
• Device Lot Number: 191020319R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1