POWERED 60 ECHELON +, 440MM SHAFT Adverse Event — Malfunction (MDR 3005075853-2020-02356)
POWERED 60 ECHELON +, 440MM SHAFT Adverse Event — Malfunction (MDR 3005075853-2020-02356) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: POWERED 60 ECHELON +, 440MM SHAFT; Generic name: STAPLE, IMPLANTABLE; Manufacturer: ETHICON ENDO-SURGERY, LLC..
| Device | POWERED 60 ECHELON +, 440MM SHAFT |
|---|---|
| Generic name | STAPLE, IMPLANTABLE |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Report number | 3005075853-2020-02356 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | PRODUCT COMPLAINT # (B)(4). CORRECTED DATA: INVESTIGATION SUMMARY: UPON VISUAL INSPECTION OF EIGHT PHOTOS, THE FOLLOWING WAS OBSERVED: THE FIRST PHOTO SHOWS A DEVICE FROM LATERAL SIDE ON HANDS OF USER WITH A BATTERY LOADED AND THE JAWS IN OPEN POSITION. THE SECOND AND SEVEN PHOTOS SHOWS A DEVICE FROM JAWS AREA AND THE ANVIL AND CHANNEL AREA APPEARS TO BE AS EXPECTED. THE FOURTH PHOTO SHOWS A DEVIC |
| Source | openFDA MAUDE (device adverse events) |
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