MAUDE Adverse Event Report: CONMED ELECTROSURGERY GOLDVAC PUSH BUTTON SMOKE EVACUATION PENCIL, 10' TUBING; GOLDVAC PENCIL

Catalog Number	60-7510-005
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/17/2016
Additional Manufacturer Narrative
The goldvac push button smoke evacuation pencil, with 10' tubing, was not returned to conmed for evaluation regarding a complaint of "electrode caught on fire" for the device was retained by the hospital facility.No visual evidence (photographs) of the damaged device were made available.A failure analysis of the complaint device could not be completed; therefore, the reported failure cannot be verified.The complaint report has stated the electrode was not a conmed goldvac electrode.The goldvac pencils are designed to work specifically with the conmed goldvac ultraclean electrodes; these electrodes each have three (3) wings that work centering the electrode correctly within the vacuum nozzle tube.This lot was manufactured on 07-dec -2015.A review of the device history record for this lot found no non-conformances or abnormalities during the manufacturing process that could have caused or contributed to the reported issue.There have been (b)(4)other similar complaint received on this lot which contained a total of (b)(4) units.The similar complaint was for a gauze sponge catching fire at the site of the patient wound.A two (2) year review of complaint history for this device family showed a total of (b)(4) complaints for fire or fire at tip of device, including this complaint.During this same two (2) year period, over (b)(4) units were sold worldwide making the occurrence rate for this reported failure mode (b)(4) percent.Based on the follow-up investigation, it was discovered that the device was being utilized to cauterize the tonsil beds, and, that the electrode was not cleaned during the procedure.To have a "flame" or "fire" at the tip of the active electrode three (3) items are required, a fuel source, an ignition source, and oxygen.During the use of coagulation (cauterization) tiny bits of tissue will stick to the active electrode.As the electrode tip remains hot and during re-activation of the electrode the tissue debris changes into eschar which can be flammable and becomes a fuel source.Since the eschar can impede the flow of electrical current, the resistive heating of the active electrode tip (ignition source) will increase.If oxygen is present, the fire triad is complete and the fuel source will ignite as seen in the reported incident.It is the responsibility of the surgical scrub nurse or the surgical technician to help the surgeon keep the active electrode free of eschar; thus, preventing fires.Per (b)(4), perioperative standards and recommended practices, recommended practices for electrosurgery, recommendation iv, the active electrode should be used in a manner that minimizes the potential for injury, paragraph iv.G.States, "eschar buildup on the active electrode tip impedes the desired current flow, causing the entire unit to function less effectively and serving as a fuel source which can lead to fires".The (b)(4) guidelines then go further discussing methods to remove debris from the active electrode.Per the (b)(4), standards of practice for electrosurgery, standard of practice vi, safety principles for the proper care and handling of the monopolar active electrode, paragraph 2.D.States, "it is the responsibility of the cst (certified surgical technologist) to help the surgeon keep the tip clean of eschar.The buildup of eschar impedes the flow of the electrical current, and it can server as an ignitable fuel." if these professional standards were followed, the reported electrode tip fire could have been avoided.To reduce risk of patient injury the ifu, instructions for use, provides the following contraindications and safety tips: these devices should never be used in the presence of flammable gases, flammable prep solutions or drapes, oxidizing gases such as nitrous oxide (n2o), or in oxygen-enriched environments.Always place unused associated electrosurgical accessories in a safe, insulated location such as the provided holster when not in use.Device retained by hospital.
Event or Problem Description
The customer reported that during use of the goldvac push button smoke evacuation pencil in a pediatric tonsillectomy procedure, and as the goldvac pencil was being utilized to cauterize the tonsil beds, the user noticed there was a flash and a flame at the tip of the device.Follow-up with the user facility indicated that there was extensive charring on the medadyne electrode tip that was being utilized with the goldvac pencil.Additional information received from the user facility revealed that this incident occurred at the end of the procedure and that the fire was brief and went out by itself.There was no injury to patient or end-user of the device with this reported incident.

• Brand Name: GOLDVAC PUSH BUTTON SMOKE EVACUATION PENCIL, 10' TUBING
• Common Device Name: GOLDVAC PENCIL
• Manufacturer (Section D): CONMED ELECTROSURGERY; 14603 east fremont avenue; centennial CO 80112
• MDR Report Key: 5505474
• Report Number: 3007305485-2016-00014
• Device Sequence Number: 282037
• Product Code: GEI
• UDI-Device Identifier: 00653405056334
• UDI-Public: (01)00653405056334(17)171206(30)1(10)201512075
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K081634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/17/2016

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: 12/06/2017
• Device Catalogue Number: 60-7510-005
• Device Lot Number: 201512075
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2016
• Initial Report FDA Received Date: 03/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 53