MAUDE Adverse Event Report: CONMED ELECTROSURGERY SYSTEM 5000 ESU

Catalog Number 60-8005-001

Device Problem Insufficient Information (3190)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 10/02/2015

Event Type  Injury  

Manufacturer Narrative

The system 5000 esu is being returned to conmed corporation for evaluation; however, to date the device has not been received.A supplemental report will be submitted on completion of the quality engineering evaluation.This medwatch is associated with medwatch number 3007305485-2015-00033 filed for the conmed goldvac electrosurgical pencil.Esu not yet returned to conmed corp.

Event Description

The end-user facility reported that during use of the conmed system 5000 electrosurgical unit ((b)(4)) along with a conmed goldvac electrosurgical pencil and a 3m dispersive electrode in a procedure involving a lumpectomy of the left breast, the patient allegedly sustained third degree burns to her left chest.The third degree burn was 1cm in diameter and 1cm deep occurring under the left breast, and, this tissue area was not involved in the surgery per the physician.The burn was cleaned and the burn area sutured over.The surgery was successfully completed without further incident.The patient was held overnight after the surgical procedure for observation.No photographic evidence of the patient burn was provided by the end-user facility; however, per the physician's last follow-up the patient is doing well.

Manufacturer Narrative

The serial number of the device was recorded on return of the device to conmed for evaluation.That serial number is reflected of this report.The system 5000 esu (electrosurgical unit) was returned to conmed for evaluation.The device was examined and tested by a service technician.It was determined that the unit requires an upgrade in software from r17 to r19.However, the unit was tested and all output readings met specifications and the unit performed as intended with no abnormalities or problems noted.The complaint investigation has not identified nor confirmed any manufacturing defects.The exact cause of the alleged burn therefore could not be determined.The system 5000 esu, serial number (b)(4), was manufactured in march 2007.Service records for the unit were unable to be obtained.However, testing results showed the unit met all test requirements with no problems noted that could have caused or contributed to the alleged 3rd degree burn.A two year review of product history for this device family showed a total of five (5) patient burns; however, only this burn was resultant of an alternate site burn from the electrical return following the path of least resistance.The system 5000 esu, being a reusable capital item, the sales are taken over an eight (8) year period.During that period, over (b)(4) units were sold worldwide, making the occurrence rate for this failure mode (b)(4).To date, there have been no patient long term adverse effects reported regarding any of the reported incidents.The system 5000 esu has been designed to provide monopolar cutting and coagulation capabilities, also in addition to both bipolar coagualtion and cutting capability.An elemental understanding of electricity is key to avoiding patient burns.Didactic education is imperative when dealing with electricity in the or.Health care workers need to be familiar with the features of all the electrosurgical units being utilized in their environment and adjust their care regarding surgical prep and the procedure accordingly to the electrosurgical equipment being utilized (infection control today ict, "education in electrosurgery technology is key for patient safety", july 1, 2002).Basic safety precautions for electrosurgery in the or, (http://blog.Boviemed.Com/blog-1/9-safety-precautions-for-electrosurgery) states to "avoid skin to skin contact points.Alternate site burns can occur when skin inadvertently comes between the route from the surgical site to the return electrode.Position the patient to ensure a direct return electrode route." at the time of the reported incident it was reported that the patient's breast tissue being operated on was in contact with the patient's chest wall tissue.Based on this received information, it is believed that the reported incident is user related due to end user abstaining from padding the skin to skin contact points of the breast tissue and chest wall tissue with dry gauze.The reported "1cm deep x 1cm diameter, third degree burn" that the patient sustained was most probably due to the fact that the patient's tissue to tissue contact the electrical current always follow the path of least resistance and this point of contact provided that path.Also the description that this small burn suggested that the point of contact was small and the electrical current was not dispersed over a large enough area.The heat produced at this small site of this alternate site burn was due to the small contact point and the concentration of current through this small contact point.Based on available information it is believed that the most probably cause of the reported incident was user error related to their failure to follow instructions in the operating manual.No further action is planned at this time.To prevent a burn of this type the operator manual of the conmed system 5000 esu states in cautions for patient preparation that: - skin to skin contacts, such as between the arm and body of a patient or between the legs and thighs, should be avoided by the insertion of dry gauze.There are many warnings throughout the conmed system 5000 esu operator's manual; however, the most important warning regarding this device is stated as follows: - safe and effective electrosurgery is dependent not only on equipment design, but also on factors under the control of the operator.It is important that the instructions supplied with this equipment be read, understood, and followed in order to ensure the safe and effective use of this equipment.This medwatch report is associated with medwatch number 3007305485-2015-00033 filed for the conmed goldvac smoke evacuation pencil.

• Brand Name: SYSTEM 5000 ESU
• Type of Device: ESU
• Manufacturer (Section D): CONMED ELECTROSURGERY; 14603 east fremont avenue; centennial CO 80112
• Manufacturer (Section G): CONMED ELECTROSURGERY; 14603 east fremont avenue; centennial CO 80112
• Manufacturer Contact: stephen casanova, rn, mps ; 525 french road; utica, NY 13502-5994 ; 3156243463
• MDR Report Key: 5239163
• MDR Text Key: 31708498
• Report Number: 1720159-2015-00004
• Device Sequence Number: 1
• Product Code: FAR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K020186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 60-8005-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 11/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention