ECHELON 60 ENDOPATH STAPLER Adverse Event — Malfunction (MDR 3005075853-2020-02348)
ECHELON 60 ENDOPATH STAPLER Adverse Event — Malfunction (MDR 3005075853-2020-02348) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ECHELON 60 ENDOPATH STAPLER; Generic name: STAPLE, IMPLANTABLE; Manufacturer: ETHICON ENDO-SURGERY, LLC..
| Device | ECHELON 60 ENDOPATH STAPLER |
|---|---|
| Generic name | STAPLE, IMPLANTABLE |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Report number | 3005075853-2020-02348 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | (B)(4). BATCH #P5837V. INVESTIGATION SUMMARY: THE EC60 DEVICE WAS RECEIVED FOR ANALYSIS WITH THE CLAMPING MECHANISM DAMAGED AND WITH FOUR CARTRIDGE PRESENTS. THE RELOADS (B & E) WERE RECEIVED PARTIALLY FIRED 1/16. THE RELOADS (C & D) WERE RECEIVED PARTIALLY FIRED 1/3. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTEGRITY OF TH |
| Source | openFDA MAUDE (device adverse events) |
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