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

Model Number	E2516H-NSB
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: na/other.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device produced flame and doctor quit using it.There was no patient involvement.A photo submitted showing that the tip of the pencil had burned.
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 device produced a match size flame and doctor quit using it.Replaced with new similar device to continue the procedure.There was no patient involvement.A photo submitted showing that the tip of the pencil had burn.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned product met specification as received, except for the heat damage of the tip.Visual inspection found no defects.No electrode or holster was received.The tip of the pencil showed heat damage.The investigation of the returned equipment did not identify anything that would have caused or contributed to the reported event.Visual inspection found.No damage, except for the heat damage of the tip of the device.With a test electrode, 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 instructions 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, e specially 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 d amage.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 makes contact with 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.
Event or Problem Description
According to the reporter, the device produced a match size flame and doctor quit using it.Replaced with new similar device to continue the procedure.There was no patient involvement.A photo submitted showing that the tip of the pencil had burn.

• 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: 7778618
• Report Number: 1717344-2018-01077
• Device Sequence Number: 19133712
• Product Code: GEI
• UDI-Device Identifier: 10884524002996
• UDI-Public: 10884524002996
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K813071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2018

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: E2516H-NSB
• Device Catalogue Number: E2516H-NSB
• Device Lot Number: 72270219X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 08/21/2018; 11/05/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 09/07/2018; 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1