ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP Adverse Event — Malfunction (MDR 3005075853-2020-02343)
ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP Adverse Event — Malfunction (MDR 3005075853-2020-02343) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP; Generic name: STAPLE, IMPLANTABLE; Manufac
| Device | ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP |
|---|---|
| Generic name | STAPLE, IMPLANTABLE |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Report number | 3005075853-2020-02343 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | (B)(4). BATCH #T5DM73. INVESTIGATION SUMMARY: THE ANALYSIS FOUND THAT ONE PVE35A DEVICE WAS RETURNED WITH NO APPARENT DAMAGE AND WITH NO CARTRIDGE LOADED ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES MET THE ST |
| Source | openFDA MAUDE (device adverse events) |
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