MAUDE Adverse Event Report: CONMED CORPORATION STANDARD NON-COATED LA[AROSCOPIC ELECTRODE L-HOOK; LAP ELECTRODE

Catalog Number 60-5163-002

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burn(s) (1757)

Event Date 06/01/2015

Event Type  Injury  

Event Description

The customer reported that during use of the standard non-coated laparoscopic electrode l-hook in a laparoscopic appendectomy procedure, the patient allegedly sustained a small burn near his belly button area.As reported, the surgeon used scissors to excise a very small portion of the skin, approximately 3cm and freshened the edges to healthy tissue and closed the incision with suture.The skin was sent for pathology and the pathologist described as 3.0x0.7cm ellipse of skin excised to depth of 0.4cm.The skin area surface contains a possible scar and it is inked black.The surgeon alleged that the small area of burn appeared to be from capacitance from the electro cautery during the procedure.To date, there has been no additional information received regarding the patient latest condition or any indication that a long term adverse effect has occurred to the burn area on the patient's abdomen.

Manufacturer Narrative

The "used" standard non-coated laparoscopic electrode l-hook was returned to conmed for evaluation.Visual examination of the returned device found no evidence of defects or damage.The device was attached to a conmed electrosurgical pencil and connected to a conmed system 7500 electrosurgical unit with conmed patient plate.The electrode tip correctly sparked the patient plate in the coag as well as cut mode.The side of the distal end of the shaft insulation was then contacted onto the patient plate and no arcing was observed in either the coag or cut mode.Hypot testing was also conducted and the unit passed hypot testing requirement.In this instance, evaluation and testing of the returned electrode l-hook found the unit performed to specifications and passed all functional test requirements, with no abnormalities or problems noted.Based on the evaluation findings, it is believed that the most likely cause of this reported incident is use error related to mishandling of the device during use.A review of the dhr could not be performed, as the lot # was not provided.A two (2) year review of complaint history for the product family shows this is the only adverse effect reports received.During this same 2-year time frame, over (b)(4) units were sold worldwide, making the occurrence rate for this failure mode (b)(4).The surgeon alleged that the small burn area appeared to be from capacitance from the electro cautery during the procedure.Capacitance is the property of being able to collect a charge of electricity.A laparoscopic electrode l-hook is not designed and/or capable of collecting and/or storing a charge of electricity.This laparoscopic electrode is simply a vector to transmit the rf energy from the esu to the surgical site.The device does get extremely hot and has the ability to burn unintended tissue if the device comes in contact with said tissue.In this instance, the device most probably was set on the patient's abdomen unintentionally after activation causing the patient burn.The conmed laparoscopy instrument and electrodes is a single use, sterile solid shaft electrosurgical electrode which be connected to a wide variety of electrosurgical pencils for hand-control activation of the electrosurgical generator, or to our disposable electrosurgical cord 60-5168-0010 cable for foot-controlled activation.The instrument is indicated for use in surgical endoscopic procedures including laparoscopy, pelviscopy, thoracoscopy, etc.To reduce the risk of patient injury the ifu, instructions for use provides the following cautions and warnings: - improper use of this or any electrosurgical device can result in a patient injury.Read and become familiar with all instruction and directions before using this product and all electrosurgical devices.Refer to the operator's manual of your electrosurgical generator for proper set-up and use.Follow all manufacturers' guidelines for electrosurgical safety.- always use the lowest possible power setting to achieve the desired electrosurgical effect.- when not in use, electrosurgical instruments should be placed in a suitable holder or site which will prevent current flow to the patient or the surgical drapes, should the operator accidentally activate the electrosurgical generator.

• Brand Name: STANDARD NON-COATED LA[AROSCOPIC ELECTRODE L-HOOK
• Type of Device: LAP ELECTRODE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 599
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 599
• Manufacturer Contact: vickie ingle ; 525 french rd; utica, NY 13502 ; 3156243053
• MDR Report Key: 4918202
• MDR Text Key: 6010058
• Report Number: 1320894-2015-00021
• Device Sequence Number: 1
• Product Code: HFG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/16/2015

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: Other
• Device Catalogue Number: 60-5163-002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2015
• Initial Date FDA Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 90