SIGNIA Adverse Event — Malfunction (MDR 1219930-2020-01870)
SIGNIA Adverse Event — Malfunction (MDR 1219930-2020-01870) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SIGNIA; Generic name: STAPLE, IMPLANTABLE; Manufacturer: COVIDIEN LP LLC NORTH HAVEN.
| Device | SIGNIA |
|---|---|
| Generic name | STAPLE, IMPLANTABLE |
| Manufacturer | COVIDIEN LP LLC NORTH HAVEN |
| Report number | 1219930-2020-01870 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | FOREIGN, USER FACILITY |
| Narrative | EVALAUTION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE SIGNIA POWERED HANDLE FOR A NON-REPORTABLE CONDITION. DURING THE INVESTIGATION A SECONDARY CONDITION OF VENTED BATTERIES WAS DETECTED. THIS CONDITION HAS A POTENTIAL FOR PATIENT HARM. VISUAL INSPECTION OF THE OPENED HANDLE FOUND THE BATTERY WAS VENTED, WET WITH ELECTROLYTIC FLUID. A REVIEW OF THE DEVICE HISTORY RECORD INDICAT |
| Source | openFDA MAUDE (device adverse events) |
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