POWERED PLUS LONG 45 Adverse Event — Malfunction (MDR 3005075853-2020-02345)
POWERED PLUS LONG 45 Adverse Event — Malfunction (MDR 3005075853-2020-02345) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: POWERED PLUS LONG 45; Generic name: STAPLE, IMPLANTABLE; Manufacturer: ETHICON ENDO-SURGERY, LLC..
| Device | POWERED PLUS LONG 45 |
|---|---|
| Generic name | STAPLE, IMPLANTABLE |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Report number | 3005075853-2020-02345 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | (B)(4). DATE SENT: 5/18/2020. D4: BATCH # P5604E. DEVICE ANALYSIS: THE ANALYSIS FOUND THAT ONE PLE45A DEVICE WAS RETURNED WITH NO APPARENT DAMAGE AND WITH NO CARTRIDGE LOADED ON THE DEVICE. THE MANUAL OVERRIDE DOOR WAS OUT OF POSITION AND MISSING. THE OVERRIDE LEVER WAS UP, WHICH DENOTES THAT THE KNIFE WAS MANUALLY RETURNED TO HOME POSITION. IT SHOULD BE NOTED AFTER THE MANUAL OVERRIDE SYSTEM IS U |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →