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

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

Over the past 2 years, MedSun has received 36 reports where patients receive a burn in association with the use of electrosurgical cutting and coagulation devices [2]. These reports represent devices across 15 different manufacturers:
• 18 reports for Valleylab,
• 4 reports for Arthrocare,
• 3 reports for ConMed,
• 3 reports for Intuitive Surgical,
• 2 reports for Boston Scientific,
• 2 reports for Megadyne,
• 2 reports for Olsen, and
• 1 report for the following manufacturers: Angiodynamics, Mizuho, Salient, Cardima, Gyrus, Encision, Depuy Mitek, Cardinal Health.

The reports were submitted by 30 hospitals received Between May 2007 and May 2009.

The reported device problems in these reports include:
• Degraded insulation
• Arcing
• Spark
• Heat
• Holes


None of reports involve a patient death. The patient injuries listed below were reported in 18 of 36 reports noted to be associated with patient burn:
• 3 reports of 3rd degree burn
• 3 reports of tissue damage
• 5 reports of additional therapy/surgery
• 2 reports of aborted surgery

Of the reports that listed patient age, six reports had a patient age listed as less than 21 years and 30 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 23 reports involved female patients and a total of 8 reports involved male patients.

These MedSun reports contributed to FDA awareness of the device problems.










MedSun Reports Associated with Electrosurgical Cutting and Coagulation device and Patient’s Burns.
Device Device Identifiers Event Description
ANGIODYNAMICS, INC. Brand name: STARBURST SEMI-FLEX, Type of device: Catheter, ablation, RF, tumor Lot # 952314, Model # 700-102-615 Patient had femur osteoid osteoma. While undergoing radiofrequency ablation of femur tumor in interventional radiology a probe was placed, and it did not work at the site of the tumor. The probe did cause a burn of approximately 2 cm x 1 cm on the skin of the patient at the insertion site. Replaced probe with another one and it worked appropriately. Patient recovering without incident.
ValleyLab, Brand name: FORCE FX, Type of device: ESU Product# Unknown Physician wanted to utilize the harmonic scalpel yet pressed ESU foot pedal instead of harmonic scalpel foot pedal. Patient experienced burn of less than 0.5 cm on upper left abdomen when the ESU endoshears were mistakenly activated.
MFR#1: CONMED ELECTROSURGERY, Device#1: Type of device: ESU device, MFR#2: Olsen Medical, Device#2: Type of device: electrosurgical forceps Device#1: Catalog # 20-1370, Model #5000, Lot #003163, Device#2: Catalog#: 20-1310 The physician was performing a tonsillectomy. It was noticed that the patient had received a burn to the upper lip at the point of contact with the bipolar forceps.
MIZUHO AMERICA, INC., Brand name: BAY PROBE INSULATED BLUE WITH SPRING, Type of device: Transnasal Transsphenoeidal instrument set Model # ISOLATED BAYONET SPRING 110MM ITEM 07-824-02 During transnasal transsphenoidal (TNTS) surgery, the physician used the bay probe insulated blue with spring (bovie stick) inside the patient's nose. Physician noted a burn on the patient's left base of the nose, about 1 cm. Physician inspected the bay probe insulated blue with spring; there were two holes in the insulation.
SALIENT SURGICAL TECHNOLOGIES, INC., Brand name: AQUAMANTYS 2.3 BIPOLAR SEALER, Type of device: ESU Device #1: Model # Aquamantys 2.3 Pediatric patient taken to surgery for liver mass. A bipolar electrosurgical device was used during the procedure. A grounding pad was placed on the left shoulder. After the procedure, it was discovered that the patient sustained two burns to the left shoulder area. The first burn was a 1.5cm.x1cm full thickness burn and located on the superior aspect of the left shoulder, slightly posterior. The second burn was also full thickness, and measured 2cm x 3cm and was located on the upper back just lateral and inferior to the spine of the scapula.
ARTHROCARE CORPORATION, Brand name: Coblator II procise EZ wand with integrated cable, Type of device: ESU hand piece Model # EIC8870-01, Lot # L123570-ASurgeon using coblator for dissection/hemostasis during tonsillectomy. Small area of metal at the tip of the insulated hand piece became exposed and conducted energy to patient's tongue, resulting in approximately 1cm burn to the right proximal area. No treatment needed.
MFR#1: CARDIMA, Device#1:Brand name: Intellitemp Energy Management device, Type of device: Cardiac RF ablation, MFR#2: Covidien ValleyLab, Device#2: Brand name: Force FX, Type of device: ESU unit, Device#3: Type of device: ESU disperser electrode Device#1:Model # 0075-04435, Catalog # 11-081008, Device#2 and 3: Product# UnknownThe patient was admitted for an atrial ablation procedure. The thoracotomy incision was made and the Valleylab Force FX Bovie was being used along with the Valleylab grounding pad. During the ablation portion of the procedure, the grounding pad was disconnected from the Valleylab Machine and connected to the Cardima Intellitemp Machine. The ablation equipment was then connected to the Valleylab Machine and after the ablation was complete, a burn was noted on the patient's right buttock, where the grounding pad was placed.
VALLEYLAB, Brand name: REM POLYHESIVE II, Type of device: ESU grounding pad Catalog # E7507, Lot #125319The cautery/ESU grounding pad was placed on the patient for a port removal procedure. When taking the pad off the patient, a reddened area around the edge of the pad was seen with some breakdown of the skin at the cord entrance site. The wound was classified as a small blister or a burn injury at the site.
ARTHROCARE CORPORATION, Brand name: Arthrocare, Type of device: Arthroscopy wand Catalog # ASC4250-01, Lot # A226570-A When drapes were removed the physician observed a tract like appearance on the medial aspect of patient's left knee (operative leg). It was described as looking like an "inside out" burn.
ARTHROCARE CORPORATION, Brand name: Coblation hand piece, Type of device: ESU handpiece electrode Lot#: B207570-AThe patient was undergoing a tonsillectomy and adenoidectomy. The surgeon was using the hand piece inside the tonsillar area to remove the tonsils and adenoids. The surgeon stated that while he was using the hand piece inside of the patient's throat he saw it "arc" causing a superficial burn. Both pieces of the apparatus were removed and sent to the biomedical department. The sales representative was also notified of the incident.
GYRUS MEDICAL, INC., Brand name: Everest Bipolar Bicoag, Type of Device: ESU Forceps Model#: 3005 5MM, 33CM, Lot#: 7352014 The physician was using the Everest bipolar cutting forceps when it was noted to be burning the tissue, sticking to the tissue and ripping it. The device was cleaned by the scrub nurse with no improvement. The procedure was stopped
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 was under conscious sedation for the insertion of a portacath to infuse chemotherapy into right external jugular vein. ESU pencil was being used to control bleeding. The patient was receiving 6l (six liters) of oxygen via facemask and surgical site had been prepped with chloraprep (which contained 70% alcohol). The anesthesiologist saw two separate flames, one behind patient's right ear and one on right side of facemask. Anesthesiologist then pulled off the facemask and patted flames with blue towel. Scrub (staff member) poured a bowl of sterile saline on patient's face and surgeon pulled all drapes off of the patient. Procedure was abandoned, and the patient was examined with the wounds dressed. The patient was taken into recovery and seen by a burn surgeon and plastic surgeon. Second degree burns were seen at the 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 their 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..
ARTHROCARE CORPORATION, Brand name: Coblator II Procise XP, Type of device: ESU Coblation electrode Catalog#: EIC8872-01, Lot#: R727470-A Patient received anesthesia for tonsillectomy and adenoidectomy using a coblator. Equipment checked preoperatively for defects and visually appeared to be normal in appearance. Patient sustained burn to right side inner bucchal mucosa. Coblator wand inspected and found to have missing insulation on external surface of the wand. Injury documented with images on digital camera./TD>
CONMED ELECTROSURGERY, Type of device: ESU suction coagulator electrode Lot#: 07FHL05 Physician was doing an adenoidectomy on this patient. They were using the bovie and thinks there was a small break in the coating of the instrument that caused the patient burn. Dr. stated that there was a small area on the uvula that was affected.
COVIDIEN VALLEYLAB, Brand name: FORCE II, Type of device: ESU unit Model#: 51500 During a c-section the physician was holding a hemostat. When the cautery was used on the hemostat, it burned a hole in the glove, causing a small burn to the physician's thumb. The physician reported the burn to be the size of a pencil eraser. The hemostat was shiny, the first time the physician had seen it. No adverse outcome to patient.
VALLEYLAB, Device#1: Brand name: SOLID STATE ELECTROSURGERY FORCE IC, Device#2: Type of device: ESU needle tip electrode, Device#3: Type of device: ESU suction coagulation electrode Device#1: Model# 590B; Device#2 and # Product# Uknown Patient was scheduled for a tonsillectomy and adenoidectomy. Patient had a previous history of adenotonsillar hypertrophy that was thought to cause dysphagia for solid consistencies. During the surgery, yet after the dissection of the first tonsil, a 4-mm right lower lip burn was noticed. Ice was immediately placed on the area in addition to a layer of Vaseline. The cautery, both needle-tips and suction were disconnected and sent to biomed for evaluation. The rest of the procedure continued without incident. After the procedure was completed, the surgeon referred the child to a plastic surgery specialist. The surgeon involved also contacted the plastic surgeon to discuss the case and identify any immediate interventions. The biomed completed an inspection of the equipment. All equipment passed visual inspections, which included no evidence of nicks, cuts or abrasions. Tests revealed that the equipment met manufacturer's specifications of output and voltage.
MFR#1: ENCISION, INC., Device#1: Brand name: AEM, Type of device: Active electrode monitor, MFR#2: COVIEDEN VALLEYLAB, Device#2: Brand name: Force II, Type of device: ESU generator /Device#1: Model# Encision, Device#2: Product# Unknown Per the physician, the patient received a small electrical burn to the upper right quadrant of the abdomen. The grounding pad, as well as the cautery cords was properly connected. No alarms sounded and the equipment functioned without shutdown. The burns were received near the very end of the case, when the ball tip cautery was being used inside. The trocar was also in use, which has an eyepiece lens attached at a 90 degree angle. When the doctor moved the lens from the patient's abdomen, the scrub tech saw the red spots on the patient, and an investigation immediately began. The red spots were directly under the lens placement and were the width of the lens. The doctor had already finished with the cautery at this point. It was immediately removed and taken out of service. The company representative was contacted. The cautery cords were left intact in the machine for the clinical equipment staff to check and investigate further. There were no visible breaks in the insulating sheaths on the green cautery equipment. The OR supervisor came to the operating room to view the burn. No further treatment was required for the patient, as the physician instructed for the area to be left open. The burn area totaled approximately 1 inch in diameter, was reddened with about three small whitish streaks inside the reddened area. No blisters were observed. This event could not be duplicated. We tried to touch the cautery tip to the eyepiece but could not because of the inflexibility of the cautery. An active electrode monitoring device was also used during this case, and it did not alarm for any stray current. The ESU and the active electrode monitor were both checked by clinical equipment and both devices functioned within normal established limits. The active electrode monitor is under a service contract and was only checked for electrical safety. The ESU received a PM approximately five months prior and functioned within normal established limits at that time.
MFR#1: BOSTON SCIENTIFIC CORP., Device#1:Brand name: RF 3000, Type of device: RF Ablation System; MFR#2: Covidien Valleylab, Device#2; Brand name: Standard Polhesive, Type of device: ESU return electrode pad Device#1: Catalog# CS545, Model# RF3000; Device#2: Catalog# E7506, Lot# 128795 Patient underwent a liver ablation under CT guidance. After the ablation was done, the grounding pads were removed from patient's thighs. Once the grounding pads were removed, the burns were noted on the lower and upper part of the left thigh pad and the lower right thigh pad. The burn on the lower right thigh was worse than the left.
COVIDIEN VALLEYLAB, Brand name: FORCE FX, Type of device: ESU generator Product# Unknown A spark was noted at the time of the tracheostomy at the insertion site, while a bleeder was being cauterized. Oxygenation was stopped immediately, the endotracheal tube removed, and a tracheal tube inserted. The trachea was flushed with normal saline, cleaned and suctioned. A fiber optic evaluation of the trachea and bronchi was done, which revealed a possible second degree burn.
MFR#1: TRI-ANIM, Device#1:Brand name: Metzenbaum, Scissors, Type of device: Surgical Scissors, Device#2: Type of device: Scissors handle, MFR#2: Cardinal Health, Device#3: Brand name: Presource Custom, Type of device: ESU cable; MFR#3: ConMed Electrosurgery, Device#4: Brand name: SABER, Type of device: ESU unit, Device#5: Type of device: ESU Dispersive electrode Device#1: Model# 810-01-21218, Lot# 44691, Device#2: Product# Unknown, Device#3: Catalog# SID23MCUB, Lot# 468976; Device#4 Model# 60-5600-02, Device#5 Catalog# 410-220 Areas of endometriosis were excised, utilizing monopolar scissors, from the right and left posterior broad ligaments, the right posterior cul-de-sac, and the right and left anterior cul-de-sac. After completing the last part of the procedure, the right posterior cul-de-sac, the surgeon noticed a cautery injury on the posterior wall of the uterus, which was made hemostatic with bipolar cautery graspers. The surgeon then noted this on the medial pole of the right ovary and on an approximately 1.5 cm segment of the right fallopian tube. It appeared that somewhat less than half the diameter of the right tube had been cauterized. Fragments of black plastic material were noted in the pelvis, which seemed to be portions of insulation from the monopolar scissors. The scissors were removed and inspected. There were clear defects in the insulation on the scissor tip, and evidence of heat damage to the distal tip of the scissor shaft itself. The bovie machine settings were coag 40 and cutting 40.
COVIDIEN VALLEYLAB, Device#1: Brand name: COOL TIP, Type of device: RF ablation controller; Device#2: Brand name: Cool TIP, Type of device: Peristaltic pump; Device#3: Brand name: COOL TIP, Type of device: RF ablation system; Device#4: Brand name: COOL TIP, Type of device: RF ablation grounding pad; Device#5: Brand name: COOL TIP, Type of device: RF ablation electrode kit Product# Unknown A patient was treated with radio frequency ablation for an osteoid osteoma of the left femur. Upon completion, a burn under the grounding pad was noted. The patient also required surgery to remove a left thigh necrotic seroma status post radio frequency ablation (rfa). Two grounding pads had been used, one on each thigh. A draining sinus was also noted along the initial application port of the probe. This was resected during the subsequent surgery
DEPUY MITEK (A JOHNSON AND JOHNSON COMPANY), Brand name: VAPR, Type of device: ESU Irrigation, suction system Product# UnknownVAPR system was used for arthroscopic surgery. It was noted during surgery that the suction had not been set up correctly causing the heated fluid to pool and cause the burn. There was not a continuous flow of irrigate. Equipment was unrecoverable and had already been thrown away or cleaned. Patient complained of burning sensation on neck in post anesthesia care unit. A 6 x 3 inch area was noted with two blisters anterior to neck. Iodoform and gauze dressing applied. Family instructed to continue Silvadene and gauze dressing after discharge for ambulatory surgery.
VALLEYLAB, Brand name: BOVIE FX, Type of device: ESU device Model# FX Surgeon noted a bovie spark. After surgery the surgeon noted that there was a small hole on the small finger of his right glove. His small finger had a burn where the spark had gone through glove; burn treated with Silvadene; no other treatment needed. Equipment was checked by biomed; no problems found and it was returned to service.
BOSTON SCIENTIFIC, Device#1: Brand name: RF 300 RADIOFREQUENCY SYSTEM, Type of device: ESU, RF Ablation; Device#2: Brand name: Coaccess Introducers set, Type of device: ablation Electrode Introducer; Device#3: Brand name: Leveen Superslim Needle Electrodes, Type of device: RF Ablation Electrode Device#1: Model#26-220, Catalog# M001262200, Device#2: Catalog# 26-225, Model# M001262250, Device#3: Catalog# 26-228, Model# M001262280 At the end of the radio ablation procedure, the radiologist noted a posterior shoulder burn near the entrance of the radio frequency needle. Metal hemostat was used by radiologist (per recommendation of the Boston scientific sales representative that was present for the procedure), to stabilize the needle in the patient's lung, thus preventing the tip of needle from moving when ablating tumors. Visual examination of the radio frequency needle and introducer set with hemostat still attached was done following the procedure. A break in the insulation sheath of the introducer was noted
COVIDIEN (VALLEYLAB), Brand name: ESU Hand piece Product# Unknown The physician laid the hand piece, which had been previously used, on the patient's chest. It began to burn the skin. The physician immediately picked it up, but the skin was already burnt. The burn was a half inch long. The hand piece was not activated (the button was not pushed) and should not have been hot.
MEGADYNE MEDICAL PRODUCTS, INC., Brand name: EZ CLEAN, Type of device: ESU electrode Catalog# 0014A, Lot# 71330 During intraoperative use of bovie tip, 4" EZ clean caused burn on patient's left breast due to failure of protective insulation on tip. Patient has multiple dermal burns approximately 1cm in diameter on the left breast.
VALLEYLAB, Brand name: FORCE TRIAD, Type of device: ESU device Product# Unknown Patient was burned during her procedure by one of the instruments being used. Events discussed with MD who referred to them as 3rd degree burns along incision line and was able to excise the damaged tissue. According to the information provided by the OR techs, there was never any spark, or abnormality during the case until the end when the retractors were removed. At that time the area was noted to be red. This machine was brand new and had been tested and cleared upon delivery by biomedical engineering. Biomedical engineering has examined the equipment and they are unable to replicate the error / problem.
VALLEYLAB, Brand name: FORCE TRIAD, Type of device: ESU device Product# Unknown Patient was burned during her procedure by one of the instruments being used. Events discussed with the MD who referred to them as 3rd degree burns along the incision line and was able to excise any/all damaged tissue. According to the techs there was no sparks or abnormalities until the end of the procedure when the equipment flashed an error and stated notify biomed. The equipment was removed from service at this point. It was not until this case that they realized that there was an equip issue as this was patient #2 with the same burn as the case before.
COVIDIEN VALLEYLAB, Brand name: ESU PENCIL, Type of device: ESU Monopolar active electrode Catalog# E2516W, Lot# 119864 Small area of pt skin around incision site burned with use of cautery. The cautery was being used inside of neck and slipped. Small burn noted pink in color on upper left hand side of incision at end of case. Antibiotic treatment and 2x2 tegaderm placed.
OLSEN MEDICAL, Brand name: OLSEN, Type of device: Bovie Extender Lot# 110802 During a partial glossectomy, a superficial burn was noted just right of midline of the patient's lower lip and corresponding to the edge of the bovie extender. Extender was immediately removed. The inside rim of the extender, about 1/4 inch, was noted to have what appeared to be crack in the sheath. Char marks on exterior of extender and outer plastic coating appears melted.
INTUITIVE SURGICAL, INC., Brand name: DAVINCI SURGICAL SYSTEM, Type of device: ESU shears cover, Robotic device PRODUCT # Unknown During robotic assisted surgical procedure for laparoscopic hysterectomy with shears set at recommended level of 38 coag, arcing occurred causing burn to uterine tissue. No harm to patient since uterus being removed. Tip cover inspected before procedure and placed on shears according to company recommendations
INTUITIVE SURGICAL, INC., Brand name: DAVINCI SURGICAL SYSTEM, Type of device: ESU shears cover, Robotic device Product# Unknown Arc/spark occurred during use, a few minutes into case. Burn to uterus resulted. No harm to patient since uterus being removed. Tip cover then noted to have holes. Removed and replaced. A machine setting was at 38 coag per manufacturer recommendations. Also tip cover inspected prior to application using gage unit and applied as recommended.
INTUITIVE SURGICAL, INC., Brand name: DAVINCI SURGICAL SYSTEM, Type of device: ESU shears cover, Robotic device Product# Unknown Arc/spark occurred during robotic assisted surgery through scissor guard / accessory tip cover causing burn to uterus which was being removed. No harm then to patient. A setting for shears was at 38 coag which is recommended level. Tip cover inspected prior to application using gage provided by company. Also application of tip cover performed according to recommendations.
MFR#1: COVIDIEN VALLEYLAB; Device#1: Brand name: HANDSWITCHIN ROCKER SWITCH PENCIL, Type of device: ESU pencil; Device#2: Brand name: Force 2, Type of device: ESU generator; MFR#2: Megadyne Medical Products, Inc., Device#3: Brand name: E-Z Clean Blade Electrodes; Type of device: ESU electrode Device#1:Catalog# E2515, Lot# 1387182013-03; Device#2: Model# Force 2-2PCH; Device#3: Catalog# 0012M, Lot# 2010-1172041 An alternate site burn occurred at the left corner of the patient's mouth during a tonsillectomy.
COVIDEN LAB, Brand name: Electrosurgical pencil Model# 145136, Lot# 146503 Using general anesthesia via mask, about 1 minute into procedure flames under drapes at right side of face while using cautery. Cause 2nd degree burn to pt face
VALLEYLAB, Device#1: Brand name: Force FX, Type of device: ESU, Device #2: Brand name: Ligasure, Type of device: ESU vessel sealing Device#1: Model# Force FX, Device#2: Model# LigasurePatient undergoing resection of large liver tumor. After surgery, patient had two burns on the left shoulder and back approximately 7 cm in diameter which required surgical debridement and flap closure.


Additional Information:

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

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


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