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

Model Number	E2516H
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned product met specification as received.Visual inspection found no defects.No electrode or holster was received.The investigation of the returned equipment did not identify anything that would have caused or contributed to the reported event.The investigation found no evidence of excessive heating or sparking on the returned pencil.The device was plugged into a generator and activated with satisfactory results.No abnormal sparking occurred.The device passed hipot testing indicating no electrical leakage.The investigation found the device to function normally and within specifications.The instructions for use (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 as sure 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, during excision soft tissue mass on back and on forearms, the doctor had completed the excision of soft tissue mass on the back and moved to the forearm.The doctor made the incision and then used the cautery pencil to cauterize the bleeding.As the doctor was moving to lay the pencil down, the tip caught on fire.The doctor immediately immersed the pencil in the basin of fluid on the sterile field.Handpieces and the generator were removed from the operating room and replaced with different generator and new disposables.There was no harm to the patient.

• 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: 8357988
• Report Number: 1717344-2019-00216
• Device Sequence Number: 13873728
• Product Code: GEI
• UDI-Device Identifier: 10884524000053
• UDI-Public: 10884524000053
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K813071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/21/2019

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 Expiration Date: 11/12/2023
• Device Model Number: E2516H
• Device Catalogue Number: E2516H
• Device Lot Number: 83110234X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1