FLEX 60 ARTICULATING Adverse Event — Malfunction (MDR 3005075853-2020-02367)
FLEX 60 ARTICULATING Adverse Event — Malfunction (MDR 3005075853-2020-02367) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: FLEX 60 ARTICULATING; Generic name: STAPLE, IMPLANTABLE; Manufacturer: ETHICON ENDO-SURGERY, LLC..
| Device | FLEX 60 ARTICULATING |
|---|---|
| Generic name | STAPLE, IMPLANTABLE |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Report number | 3005075853-2020-02367 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | (B)(4). DATE SENT: 5/21/2020. D4: BATCH #T5EK8A. INVESTIGATION SUMMARY THE ANALYSIS FOUND THAT ONE EC60A DEVICE (B) WAS RETURNED WITH NO APPARENT DAMAGE AND WITH AN ECR60D CARTRIDGE RELOAD LOADED ON THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED FULLY FIRED. AFTER FURTHER ANALYSIS THE ARTICULATION MECHANISM WAS NOTED TO BE DAMAGED, AS IT WOULD NOT HOLD THE ARTICULATION SETTING. THE DEVICE WAS TESTE |
| Source | openFDA MAUDE (device adverse events) |
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