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

Model Number	E2515HNSB
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2019
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, the tip of the bovie pencil caught fire size of birthday candle flame.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned products met specification as received.Visual inspection of the device showed no defects.The reported condition was not confirmed.Visual inspection found no defects.The electrode was attached to each of the returned pencils and activated at 60w.No flame or abnormal effects was noted.No defects were detected with the device.The investigation found the devices to function normally.The 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, during the surgery, the tip of the bovie pencil caught fire size of birthday candle flame.The flame disappeared on its own after a few seconds.The affected cautery pencil was passed off the sterile field right away, and a new product was used throughout surgery with no issues with the same generator.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: 8872391
• Report Number: 1717344-2019-01023
• Device Sequence Number: 14276561
• Product Code: GEI
• UDI-Device Identifier: 20884524003648
• UDI-Public: 20884524003648
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K813071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2019

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: E2515HNSB
• Device Catalogue Number: E2515HNSB
• Device Lot Number: 191020319R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 09/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1