SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (14CM) Adverse Event — Malfunction (MDR 1317056-2020-00075)
SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (14CM) Adverse Event — Malfunction (MDR 1317056-2020-00075) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (14CM); Generic name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES; Manufacturer: AN
| Device | SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (14CM) |
|---|---|
| Generic name | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES |
| Manufacturer | ANGIODYNAMICS |
| Report number | 1317056-2020-00075 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | RETURNED FOR EVALUATION WAS A SOLERO PROBE. THE RETURNED PROBE WAS REVIEWED BY R&D AND CONFIRMED THE CERAMIC TIP WAS FRACTURED AT THE END OF THE SEMI-RIGID SLEEVE. THE ROOT CAUSE OF THE FRACTURE WAS A THERMAL EVENT THAT OVER-HEATED THE SEMI-RIGID CAUSING THE CERAMIC TIP TO FRACTURE. THE ROOT CAUSE OF THE THERMAL EVENT CANNOT BE DEFINITELY DETERMINED BUT IS POTENTIALLY RELATED TO A VARIATION IN THE |
| Source | openFDA MAUDE (device adverse events) |
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