PWRD ECH FLEX 60MM 34CM SHAFT Adverse Event — Malfunction (MDR 3005075853-2020-02354)
PWRD ECH FLEX 60MM 34CM SHAFT Adverse Event — Malfunction (MDR 3005075853-2020-02354) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PWRD ECH FLEX 60MM 34CM SHAFT; Generic name: STAPLE, IMPLANTABLE; Manufacturer: ETHICON ENDO-SURGERY, LLC..
| Device | PWRD ECH FLEX 60MM 34CM SHAFT |
|---|---|
| Generic name | STAPLE, IMPLANTABLE |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Report number | 3005075853-2020-02354 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | (B)(4). DATE SENT: 5/18/2020. D4: BATCH # T5EK3W. DEVICE ANALYSIS: THE ANALYSIS FOUND THAT ONE PSE60A DEVICE WAS RETURNED WITH NO APPARENT DAMAGE AND WITH AN ECR60B CARTRIDGE RELOAD LOADED ON THE DEVICE. THE CARTRIDGE WAS RECEIVED PARTIALLY FIRED 1/16 WITH ONE PIECE SLED DAMAGED. IN ADDITION, ANOTHER ECR60D RELOAD (B) WAS RECEIVED FULLY FIRED WITH FOUR DOUBLE DRIVERS MISSING AND ONE DOUBLE DRIVER |
| Source | openFDA MAUDE (device adverse events) |
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