ECHELON FLEX 45 STANDARD Adverse Event — Malfunction (MDR 3005075853-2020-02360)
ECHELON FLEX 45 STANDARD Adverse Event — Malfunction (MDR 3005075853-2020-02360) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ECHELON FLEX 45 STANDARD; Generic name: STAPLE, IMPLANTABLE; Manufacturer: ETHICON ENDO-SURGERY, LLC..
| Device | ECHELON FLEX 45 STANDARD |
|---|---|
| Generic name | STAPLE, IMPLANTABLE |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Report number | 3005075853-2020-02360 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | (B)(4). DATE SENT: 5/28/2020. INVESTIGATION SUMMARY THE ANALYSIS FOUND THAT ONE EC45A DEVICE WAS RETURNED WITH NO APPARENT DAMAGE, AND WITH AN ECR45W PARTIALLY FIRED 1/10 WITH A CARTRIDGE LOADED ON THE DEVICE. THE RETURNED DEVICE AND CARTRIDGE RELOAD WERE TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION BY RESETTING AND RELOADING IT INTO THE DEVICE. THE DEVICE ACHIEVED ITS COMPLETE STROKE FIRI |
| Source | openFDA MAUDE (device adverse events) |
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