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

Model Number	E2516HS
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/10/2018
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, the blue plastic part that connects the metal of the bovie pencil to the white part of the pencil lit on fire like a lighter flame.The doctor blew the flame out and opened a new pencil.There was no patient involvement.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned product met specification as received.Visual inspection found no defects.An electrode was also received.The investigation of the returned equipment did not identify anything that would have caused or contributed to the reported event.The visual inspection found no damage to the device.The device was plugged into a 40k ohm test box and activated in both the cut and coag mode with satisfactory results.The device was plugged into a generator and activated normally.The device was hipot tested with satisfactory results indicating no electrical leakage.The investigation found the devices to function normally and within specifications.The instruction for use (ifu) states, confirm proper electrosurgical generator power setting before proceeding with surgery.Use the lowest power setting to achieve the desired surgical effect.The ifu states, both oxygen and nitrous oxide support combustion.Watch for enriched oxygen and nitrous oxide atmospheres near the surgical site, especially during head and neck surgery.Enriched oxygen atmospheres may result in fires and burns to patients or surgical personnel.Do not exceed the maximum power limits as stated in the ifu.Exceeding these power limits may result in patient injury or product damage.If the electrode is damaged, discard it.Always use the lowest power setting to achieve the desired surgical effect.The maximum power settings are detailed in the instructions for use.Some surgeons may elect to buzz the hemostats during a surgical procedure.This practice is not recommended and the hazards of such a practice probably cannot be eliminated.To minimize the risk, when using coated electrodes, place the edge of the electrode against the hemostat or metal instrument to assure a good electrical pathway.Do not activate the generator until the accessory contacts the instrument.Additional measures to minimize the risk of performing this technique are listed in the electrosurgical generator users¿ manuals.If information is provided in the future, a supplemental report will be issued.

• 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: 7735631
• Report Number: 1717344-2018-01009
• Device Sequence Number: 19237221
• Product Code: GEI
• UDI-Device Identifier: 10884524001500
• UDI-Public: 10884524001500
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K945260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2018

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: E2516HS
• Device Catalogue Number: E2516HS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 10/18/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 10/03/2018; 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1