POWERED 60 ECHELON +, 340MM SHAFT Adverse Event — Malfunction (MDR 3005075853-2020-02365)
POWERED 60 ECHELON +, 340MM SHAFT Adverse Event — Malfunction (MDR 3005075853-2020-02365) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: POWERED 60 ECHELON +, 340MM SHAFT; Generic name: STAPLE, IMPLANTABLE; Manufacturer: ETHICON ENDO-SURGERY, LLC..
| Device | POWERED 60 ECHELON +, 340MM SHAFT |
|---|---|
| Generic name | STAPLE, IMPLANTABLE |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Report number | 3005075853-2020-02365 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | (B)(4). BATCH # T5EL2E. DEVICE ANALYSIS: THE ANALYSIS RESULTS THAT ONE PSEE60A DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCE'S AND WITHOUT A CARTRIDGE RELOAD PRESENT. IN ADDITION ANOTHER GST60D RELOAD WAS RECEIVED FULLY FIRED. FURTHER ANALYSIS SHOWED A CARTRIDGE PAN WAS FOUND LODGED INSIDE THE CHANNEL. THE PAN WAS REMOVED FROM THE CHANNEL AND THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TES |
| Source | openFDA MAUDE (device adverse events) |
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