45MM ARTICNG LNR CUTR/WHT RLD Adverse Event — Malfunction (MDR 3005075853-2020-02339)
45MM ARTICNG LNR CUTR/WHT RLD Adverse Event — Malfunction (MDR 3005075853-2020-02339) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: 45MM ARTICNG LNR CUTR/WHT RLD; Generic name: STAPLE, IMPLANTABLE; Manufacturer: ETHICON ENDO-SURGERY, LLC..
| Device | 45MM ARTICNG LNR CUTR/WHT RLD |
|---|---|
| Generic name | STAPLE, IMPLANTABLE |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Report number | 3005075853-2020-02339 |
| Event type | Malfunction |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | PRODUCT COMPLAINT # (B)(4). DATE SENT: 7/13/2020. D4: BATCH # N54G5K. INVESTIGATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE ATW45 DEVICE WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AND WITH A TR45W CARTRIDGE LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED PARTIALLY FIRED 1/10 AND WITH THE RELOAD LOCKOUT SPRING DAMAGED. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. |
| Source | openFDA MAUDE (device adverse events) |
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