MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07,company representati report with the FDA on 2015-04-16 for THERMOGARD PLUS ABC DUAL DISPERSIVE ELECTRODE 7-382 manufactured by Conmed Corporation.
[5722166]
The end-user reported that the patient sustained a 2 inch, second degree burn on his left lateral thigh. Physician was utilizing an argon beam coagulator and a conmed system 7550 esu, electrosurgical unit, at settings 120 watts, with argon gas at 4. 0 lpm flow. At 5-10 seconds into the case the dispersive electrode started to spark. Argon was immediately discontinued. The burn was cleaned with saline, treated with 1% silvadene ointment and covered with gaquze. The patient was discharged from the hospital and scheduled for follow up on (b)(6) 2015. 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.
Patient Sequence No: 1, Text Type: D, B5
[13245908]
One (1) "used" thermogard? Dispersive electrode was returned to the conmed for evaluation. The device was visually examined in the laboratory and found to have a clear plastic sheet covering the gel. It was found to have a small burn area approximately 2-3mm in diameter at proximal end of the device near the electrical cord and plastic clamshell. A portion of the gel near the proximal edge contained visible charring in an area approximately 7cm long by 2cm wide. The charring was associated with the gel and foam interface. An array of char was observed splattered on the foam adhesive adjacent to the discolored gel. The splatter suggests the pad was away from the skin at the time of the charring. The cables were examined for any cuts, abrasions or any other damage; no harm to cable was observed. The device was manufactured 05-dec-2014. A review of the device history record for this lot found no noted discrepancies during the manufacturing process that could have caused or contributed to this reported incident. Special attention has been made to review the impedance tests, gel cure tests and pad gel weight tests with no nonconformance observed. Of the lot containing 3600 units, there has only been this one (1) reported patient burn. A two year review of product history for this device family showed a total of five (5) similar reports for patient burns, including this incident. (b)(4). It should be noted, of the four (4) reports of patient burns, there has been only one (1) report in which a second surgery was performed to treat the burn, surgical debridement. To date, there have been no patient long term adverse events reported regarding any of the four (4) reported events. The thermogard? Dispersive electrode is a disposable, dispersive electrode used for the dispersion and return to the electrosurgical generator of therapeutic (rf) energy introduced to the patient produced at the active electrode during electrosurgical procedures. In this instance, conmed was unable to reproduce the reported event despite numerous scenarios the device was tested against. It was discovered that the dispersive electrode application site was cleaned with alcohol prior to placing the dispersive electrode on the patient. Regarding preparation of the application site the ifu, instructions for use, states, "prepare the skin at the application site according to facility protocol. If no protocol exists, clip excess hair at application site, clean and disinfect area to remove oils, lotions, etc. , and allow to dry thoroughly. " alcohol is a flammable substance. The aorn, association of perioperative registered nurses, perioperative standards and recommended practices, section on recommended practices for preoperative patient skin antisepsis, recommendation viii, states, "if a flammable skin prep agent is used, additional precautions should be taken to minimize the risk of a surgical fire and patient burn injury. Using flammable skin prep agents in the operating room or procedural area poses a serious risk of fire because of the common use of ignition and heat sources (e. G. , electrosurgery, lasers, drills, fiberoptic cables)". Under this same section, recommendation viiie reads, "the prep agent should be allowed to dry and vapors to dissipate before application of an incise drape or surgical drape, or use of electrosurgery, laser, or other heat source. The prep agent remains flammable until completely dry. Vapors occurring during evaporation are also flammable. Trapping of solution or vapors under drapes increases the risk of fire or burn injury". The dispersive electrode may have been placed on the patient prior to the complete drying of the application site after cleaning with the alcohol. This could have trapped alcohol or vapors from the alcohol under the dispersive electrode, and, this could have contributed to the patient burn that occurred. To reduce the risk of patient injury, the instructions for use, ifu, provides the following warnings and precautions: - thermogard and thermogard plusabc dispersive electrodes are for use with various patient populations providing there is sufficient surface area to ensure full contact of the electrode with the patient's skin. Failure to achieve a good skin contact by the entire adhesive surface may result in electrosurgical burns or poor electrosurgical performance. - do not coil dispersive electrode cable or allow the cable to overlie other electrosurgical monitoring cables or equipment as the unintended transfer of potentially harmful rf energy may result. - avoid skin to skin contact when positioning the patient, using dry gauze where necessary. - if patient is repositioned, reinspect dispersive electrode and all connections. - do not re-use or re-locate the dispersive electrode after initial application.
Patient Sequence No: 1, Text Type: N, H10
[74276561]
This supplemental report corrects a minor discrepancy in information provided in the original medwatch. The corrections were identified during an internal retrospective review of medwatch reports filed for complaints received by conmed between (b)(6) 2015 and (b)(6) 2017. This review was performed in accordance with a pre-approved protocol, conmed document #(b)(4), which defined a process for performing and documenting reviews of previously submitted medwatch reports for accuracy and completeness. (device manufacturing only): corrected the manufacturing date.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1320894-2015-00009 |
| MDR Report Key | 4700119 |
| Report Source | 05,06,07,COMPANY REPRESENTATI |
| Date Received | 2015-04-16 |
| Date of Report | 2017-04-24 |
| Date of Event | 2015-03-19 |
| Date Mfgr Received | 2015-03-20 |
| Device Manufacturer Date | 2014-12-05 |
| Date Added to Maude | 2015-04-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. STEPHEN CASANOVA, RN, MPS |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal | 135025994 |
| Manufacturer Phone | 3156243463 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 135025994 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMOGARD PLUS ABC DUAL DISPERSIVE ELECTRODE |
| Generic Name | THERMOGARD GROUND PAD |
| Product Code | HAM |
| Date Received | 2015-04-16 |
| Returned To Mfg | 2015-03-23 |
| Catalog Number | 7-382 |
| Lot Number | 1412051 |
| Device Expiration Date | 2016-12-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 13502599 US 13502 5994 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-04-16 |