MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-30 for 130MM X 2.3MM DIAMETER,CONCEPT HEATWAVE ELECTRODE, QTY 5 CS-023 manufactured by Conmed Linvatec.
[32483352]
Conmed received the three concept heatwave electrodes for evaluation on (b)(6) 2015. Visual inspection of the returned devices confirmed the side of each shaft was burnt and melted in appearance and a portion of the coating was missing. Upon further analysis by r&d engineering on 11/11/2015 using microscopic inspection, longitudinal marks along the length of the shrink tubing were observed. An investigation has been opened to address this issue. This device was manufactured on 17-apr-2015 in a lot of (b)(4) units. (b)(4)). A review of the device history record showed no anomalies or non-conformances during the manufacturing process. There have not been any other adverse events reported for this device. One other complaint report was opened for this device and lot number combination when two (2) additional units were returned unopened/unused. This failure mode is addressed in the fmea and the safety risk has been found to be acceptable. The product insert provides the following precaution: 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.
Patient Sequence No: 1, Text Type: N, H10
[32483353]
It was first reported by the customer on (b)(6) 2015, that three concept heatwave electrodes burned out during a single surgical procedure before the electrode could be used on the patient. There was no patient impact. Analysis of the returned electrodes by the r&d engineer on (b)(6) 2015, found that there was an insulation failure of the shrink tubing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-2015-00074 |
| MDR Report Key | 5254667 |
| Date Received | 2015-11-30 |
| Date of Report | 2015-11-11 |
| Date of Event | 2015-11-11 |
| Date Mfgr Received | 2015-11-11 |
| Device Manufacturer Date | 2015-04-17 |
| Date Added to Maude | 2015-11-30 |
| 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 | 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, QTY 5 |
| Generic Name | ELECTRODE, ELECTROSURGICAL |
| Product Code | JOS |
| Date Received | 2015-11-30 |
| Returned To Mfg | 2015-09-30 |
| Catalog Number | CS-023 |
| Lot Number | 643395 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-11-30 |