Summary of MedSun Reports Describing Adverse Events With Electrosurgical Cutting and Coagulation Devices: Fire Associated Reports
MedSun: Newsletter #38, July 2009

An electrosurgical cutting and coagulation device (and its accessories) is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.[1]

Over the past 2 years, MedSun has received 13 reports where fire is association with the use of electrosurgical cutting and coagulation devices [2]. The reports represent devices across 8 manufacturers:
• 8 reports for Valley lab and
• 1 report for the following manufacturers: Arthrocare, Boston Scientific, Megadyne, Karl Storz, Gyrus, Integra LifeSciences Corporation, and Olympus.

The reports were submitted by 12 hospitals between May 2007 and May 2009.

The reported device problems in these reports include:
• 13 reports of fire
• 2 reports of spark
• 1 report of heat
• 1 report of arcing


None of reports involved a patient death. The patient injuries listed below were reported in 9 out of 13 reports:
• Burn
• Re-intubation
• Additional Therapy
• Wound
• Redness
• Tissue damage

Of the reports that listed patient age, 5 had a patient age listed as less than 21 years and 8 had a patient age listed as greater than 2 years. Of the reports that listed patient gender, a total of 4 reports involved female patients and a total of 7 reports involved male patients.

These MedSun reports contributed to FDA awareness of the device problems. FDA currently has this issue under review.









MedSun Fire Reports Associated with Electrosurgical Cutting and Coagulation Device.
Device Device Identifiers Event Description
Valley Lab, Brand name: FORCE FX, Type of device: ESU hand piece Model# 34828The Bovie tip spontaneously irrupted into a small flame. There was no harm to patient or staff. The situation was controlled immediately
Karl Storz Endoscopy -America, Inc., Type of device: Monopolar ESU cord Lot #:IE01During a laparoscopic appendectomy, the cautery device attached to a Maryland Kelly Dissector ignited at the level of the cord. The fire spread to the surgeon's gown and deeper into the surgeon's scrubs. The instrument was immediately removed from the patient and the fire was extinguished with the surgeon's hand. Water was doused on the surgeon's scrubs and gown and the patient's drapes. Oxygen was immediately shut off. No harm to the surgeon or patient. Later on, the case continued without incident.
Covidien LP, Formerly known as Valley Lab, Brand name: ESU, Type of Device: Hand switching suction coagulator Lot #: 151616, Catalog #: E2610-6 At the start of adenoidectomy surgery, a tongue blade and mouth gag were inserted and the mouth was opened for exposure. A red non-latex Robinson catheter was placed transnasally and brought out transorally to help elevate the palate for exposure of the nasopharynx and access to the nasopharynx. At the start of this adenoidectomy, a method of fulguration, using suction cautery, an apparent oxygen leak resulted in a spark. The red non-latex Robinson catheter ignited, and which rapidly began to smolder. A fire estimated to be the size of a fifty cent piece was observed in the oral cavity. The endotracheal tube and the red Robinson were immediately removed from the patient and the oral cavity was doused with saline, and then suctioned out. The patient was re-then intubated with an endotracheal tube. Immediate examination of the oral cavity and larynx revealed that the patient had a 0.5 cm x 2 cm burn on the left lateral tongue, as well as an 8 mm x 8 mm burn on the buccal mucosa of the right lateral lower lip. All just inferior to the crease of the oral commissure. The area was immediately iced. The burns continued to be iced and were classified as superficial and minor by the physician burn specialist. It was later treated with Neosporin. Despite no evidence of burn on the endotracheal tube, it was removed from the patient. The decision was made to confirm that there was no airway injury and direct laryngoscopy and bronchoscopy was performed with confirmation of no airway injury to the larynx or trachea to the level of the carina.

Uncuffed ETT had a large air leak that increased when neck hyperextended; 02 flow rate was high at 89%-92% at the time of event; there was no soaked gauze throat packs in place; there was red non-latex Robinson catheter in mouth; and diluted Hibiclens was being used as a dental mirror defogging agent.
Covidien Valleylab, Device#1: Brand name: Force FX-C, Type of device: ESU unit, Device#2: Type of device: ESU hand piece Product# Unknown Patient under conscious sedation for insertion of portacath for chemotherapy into right external jugular vein. ESU pencil was being used to control bleeding. Patient was receiving 6L (liters) of oxygen via facemask and surgical site had been prepped with Chloraprep (which contained 70% alcohol). Anesthesiologist saw 2 separate flames: one behind patient's right ear and one on right side of facemask.

Anesthesiologist pulled off facemask and patted flames with blue towel. Scrub poured a bowl of sterile saline on patient's face and surgeon pulled all drapes off of patient. The procedure was abandoned, and the patient examined and wounds dressed. The patient was taken into recovery and seen by a burn surgeon and plastic surgeon. Second-degree burns were found at right corner of mouth, at the base of her right ear and right side and back of her neck. They did not find any wounds in nose or mouth and the patient will have no respiratory consequence. An ophthalmologist found no injury to her eyes.

It is not known for sure what caused the adverse event, but after discussion, the causation theory is that a spark or heat from the ESU pencil ignited the blue cotton drape that must have had remnants of the alcohol-based prep used to cleanse the skin for surgery. The oxygen likely pooled in high concentration around the face mask and near the table at the base of the neck and acted as an accelerant. Chloraprep with Tint, 26mL applicator, was being used at the time of event.
Valleylab, Device#1: Brand name: Suction Coagulator, Type of device: ESU hand piece; Device#2: Type of device: ESU unit Device #1: Model #: E2505-10FR, Device#2: Model# Force FXA patient was in the OR for PE tube placement and adenoidectomy. During the procedure it was noted that the tip of the suction catheter ignited. This was immediately recognized and the suction catheter was removed and the flame extinguished. Patient was assessed and no injury, including airway trauma or burn noted.

The site reported the manufacturer told hospital that if the tip of the suction catheter becomes blocked with material, there is the potential for this material to ignite once the device is turned on.
MFR#1: Gyrus Medical, Inc. Device#1: Type of device: ESU Cable Accessory; MFR#2: Covidien Valleylab, Device#2: Brand name: Force FX, Type of device: ESU unit; MFR#3: Boston Scientific Corporation, Device#3: Brand name: Titanium Wedge electrosurgical Monopolar, Type of device: Electrode tip Device#1: Model #: RAC-B Catalog #: 31880110, Device#2: product#: Unknown, Device#3: Catalog# 880-311 Resectoscope cord caught fire while in use by physician. The fire was in the cord only, the tip was not involved. The duration of the fire was 2 seconds. The electrosurgical machine was set to maximum (120 W Coag/ 300 W cut) Patient had a 1 cm area of redness on penis. No treatment required.
Covidien Valleylab, Brand name: Electrosurgical pencil, Type of device: ESU hand piece Model #: 145436 Lot #:146503Using general anesthesia via mask, and cautery, about 1 minute into procedure flames under drapes at right side of face. Second degree burns occurred pt face.
Integra LifeSciences Corporation: Brand name: Bipolar forceps Model #:285-188Bipolar forceps burst into fire at junction where forceps is connected to the bipolar cord. Fire extinguished by itself. No harm to patient. Disposable bipolar cord came from flap pack.
Olympus Surgical and Industrial America Inc: Brand name: ESU active cable Catalog #:AO35BDuring laparoscopic cholecystectomy procedure, the end nearest to the cautery machine of the cautery cord caught fire and burned through. No harm to patient or staff.
MEGADYNE Medical Products, Inc., Brand name: Bovie tip, Type of device: ESU hand piece Catalog # 139926 Lot # 813306, Model# +M1160001399261HThe device flared at the tip when with an attempt to use it outside the patient. The case was completed successfully using another device.
Covidien Valleylab, Type of device: ESU suction coagulator electrode Model#:E2505-10FR Lot #:127510While the surgeon was cauterizing the adenoids, the oral cavity caught fire. Saline solution was poured into the mouth. There was no injury to the patient.
VALLEYLAB, Brand name: electrosurgical unit Product# Unknown During a tracheotomy the patient's O2 saturation began to drop. This required an increase in oxygen to 100%. A spillage of oxygen out of the mouth occurred into the area of the wound. There was a short flash of fire on the chest secondary to electrocautery. The fire was put out with sterile water. The patient's chest hair was singed. No apparent burn
Arthrocare Corporation, Brand name: Coblator II Procise EZ Wand with Integrated Cable, Type of Device: ESU Hand piece Model# EC8870-01, Lot# L102770-ACoblator being used for hemostasis in tonsillectomy procedure. The wand got hot, with apparent "arcing" to adjacent tissue, causing minor damage.

Additional Information:

[1] Code of Federal Regulations Title 21
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=878.4400

[2] FDA MedSun
http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm127686.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun