MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-14 for 130MM X 2.3MM DIAMETER, CONCEPT HEATWAVE ELECTRODE CS-023 manufactured by Conmed Linvatec.
[36355113]
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.
Patient Sequence No: 1, Text Type: N, H10
[36355114]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-2015-00099 |
| MDR Report Key | 5367145 |
| Date Received | 2016-01-14 |
| Date of Report | 2015-12-18 |
| Date of Event | 2015-12-17 |
| Date Mfgr Received | 2015-12-18 |
| Device Manufacturer Date | 2015-08-05 |
| Date Added to Maude | 2016-01-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. BRENDA JOHNSON |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995515 |
| Manufacturer G1 | CONMED LINVATEC |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 130MM X 2.3MM DIAMETER, CONCEPT HEATWAVE ELECTRODE |
| Generic Name | ELECTRODE, ELECTROSURGICAL |
| Product Code | JOS |
| Date Received | 2016-01-14 |
| Catalog Number | CS-023 |
| Lot Number | 667118 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | 11311 CONCEPT BLVD. LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-14 |