ATLAS20CM Adverse Event — Malfunction (MDR 1219930-2008-00115)
ATLAS20CM Adverse Event — Malfunction (MDR 1219930-2008-00115) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ATLAS20CM; Generic name: LIGASURE VESSEL SEALING SYSTEM; Manufacturer: COVIDIEN LP (US SURGICAL).
| Device | ATLAS20CM |
|---|---|
| Generic name | LIGASURE VESSEL SEALING SYSTEM |
| Manufacturer | COVIDIEN LP (US SURGICAL) |
| Report number | 1219930-2008-00115 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-11 |
| Report source | Foreign, Health Professional, User facility |
| Narrative | THE REPORT STATED THAT DURING A COLECTOMY THE LIGASURE ATLAS WAS BEING USED TO SEAL AND TRANSECT TISSUE IN THE MESENTERY. AFTER APPROXIMATELY 10 COMPLETE SEALING CYCLES, UNDER 200CC'S OF BLEEDING OCCURRED FROM THE SEALED TISSUE. THE TISSUE WAS THICK, SO THE BLEEDING DID NOT STOP EVEN THOUGH THE TISSUE WAS DIVIDED INTO A FEW LAYERS AND SEALED. THE BLEEDING AREA WAS THEN MANUALLY SUTURED. THE POWER |
| Source | openFDA MAUDE (device adverse events) |
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