MAUDE Adverse Event Report: CONMED LINVATEC 130MM X 2.3MM DIAMETER, CONCEPT HEATWAVE ELECTRODE; ELECTRODE, ELECTROSURGICAL

Catalog Number CS-023

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2015

Event Type  malfunction  

Manufacturer Narrative

The involved concept heatwave electrode is not being returned to conmed corporation for evaluation, as it was discarded at the end-user facility.In addition, no visual evidence (photographs) of the reported "fire, burnt/damaged electrode tip" was provided by the end-user.Without the involved device, an evaluation could not be performed to determine the root cause and/or to verify the reported problem.This lot #667118 was manufactured on 05-aug-2015.A review of the device history record for this lot found no noted discrepancies during the manufacturing process that could have could or contributed to alleged incident.Of the lot containing (b)(4) units, there was (b)(4) other similar complaint with a quantity of (b)(4) received from the same customer for this item and lot number combination (see mdr #1017294-2016-00004).A review of the complaint history for the device family shows there have been no serious injuries or death related to this reported problem.This alleged failure mode is addressed in the fmea and the safety risk has been found to be acceptable.However, due to similar complaints an investigation has been opened to address this reported problem.The heatwave electrodes are single-use, disposable monopolar electrodes designed for use with an electrosurgical generator via an electrosurgical pencil and a dispersive electrode (pad).The heatwave electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow, and knee arthroscopic procedures.To reduce the risk of insulation damaged and patient injury, the device instruction for use (ifu) provides the user with the following precautions and warnings: precautions: use caution when programming the power settings.Use the lowest power setting and the minimum tissue contact-time necessary to achieve the appropriate surgical effect.High power settings, and prolonged use may result in damage to the insulation, melting of the electrode tip, or patient burns.Continuous flow of irrigant is recommended.Fluid flow assists in removing debris as well as cooling the fluid in the joint and electrode tip between activations.Maintaining an outflow is important, especially in small joint spaces.Warnings: electrodes must only be used in a conductive fluid medium to avoid insulation damage.If any visual defects are noticed in the insulation, or the ceramic/insulation is damaged in any way, stop using the device immediately and replace the device.Use ablators only within prescribed generator settings.High power generator settings, and prolonged use, may result in damage to the insulation, melting of the electrode tip or increased risk of patient burns.Use care when inserting into and withdrawing the electrode from a cannula to avoid the possibility of damage to the devices and/or injury to the patient.Do not insert, withdraw or touch the active tip of the electrode when power is being applied.This may result in an unintended surgical effect, injury, or device damage.Do not bury electrode tip and insulator in tissue.The electrode tip must be completely surrounded by conductive fluid when activated in order to avoid damage to the insulation.Avoid unnecessary activation between tissue applications to avoid patient injury.Do not pry or pull tissue using the device.Insulation may be damaged.Electrical shock hazards and safety considerations: this equipment is capable of producing a physiological effect and is for use only by licensed physicians trained in the use of this device.Examine all accessories and connections to the generator before use.Ensure all accessories are properly and securely connected and function as intended.Improper connection may result in arcing, sparking, or malfunction of the device, any of which can result in an unintended surgical effect, injury, or equipment damage.Device was discarded at user facility.

Event Description

The customer reported that during use of the concept heatwave electrode in a knee arthroscopic acl procedure, the user noticed "there was fire from the electrode when it was activated".Reportedly, the fire occurred just at the beginning of being used during the acl re-tensioning and after the surgery had finished.There were no further complications reported and the procedure was otherwise completed with no patient injury and only 5 minutes delay.

• Brand Name: 130MM X 2.3MM DIAMETER, CONCEPT HEATWAVE ELECTRODE
• Type of Device: ELECTRODE, ELECTROSURGICAL
• Manufacturer (Section D): CONMED LINVATEC; 11311 concept blvd.; largo FL 33773
• Manufacturer (Section G): CONMED LINVATEC; 11311 concept blvd.; largo FL 33773
• Manufacturer Contact: brenda johnson ; 11311 concept blvd.; largo, FL 33773 ; 7273995515
• MDR Report Key: 5367145
• MDR Text Key: 36355113
• Report Number: 1017294-2015-00099
• Device Sequence Number: 1
• Product Code: JOS
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K991830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2020
• Device Catalogue Number: CS-023
• Device Lot Number: 667118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1