SIGNIA Adverse Event — Malfunction (MDR 1219930-2020-01869)
SIGNIA Adverse Event — Malfunction (MDR 1219930-2020-01869) 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 | 1219930-2020-01869 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION AND A PHOTOGRAPHIC EVALUATION OF ONE DEVICE. A VISUAL INSPECTION OF THE RETURNED PHOTO NOTED A POWER HANDLE ERROR ON THE SCREEN OF THE HANDLE. VISUAL ANALYSIS OF THE RECEIVED PRODUCT NOTED THAT THE SCREEN WAS DIM WITH A RED TINT. ANALYSIS OF SYSTEM LOGS SHOWS MULTIPLE EVIDENCE OF FIELD PROGRAMMABLE GATE ARRAY (FPGA) RESET/REPROGRAM |
| Source | openFDA MAUDE (device adverse events) |
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