75 MM NTLC SELECTABLE RELOAD Adverse Event — Malfunction (MDR 3005075853-2020-02384)
75 MM NTLC SELECTABLE RELOAD Adverse Event — Malfunction (MDR 3005075853-2020-02384) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: 75 MM NTLC SELECTABLE RELOAD; Generic name: STAPLE, IMPLANTABLE; Manufacturer: ETHICON ENDO-SURGERY, LLC..
| Device | 75 MM NTLC SELECTABLE RELOAD |
|---|---|
| Generic name | STAPLE, IMPLANTABLE |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Report number | 3005075853-2020-02384 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | (B)(4). BATCH # T5E840. DEVICE ANALYSIS: THE ANALYSIS RESULTS FOUND THAT A SR75 RELOAD WAS RECEIVED WITH THE LEFT GRIPPING SURFACE BROKEN OFF, MAKING THE RELOAD NONFUNCTIONAL. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO THE CONDITION OF THE RELOAD. THE CONDITION ON THE RETURNED RELOAD IS CONSISTENT WITH AN IMPROPER LOADING TECHNIQUE. WHEN LOADING THE CARTRIDGE IN THE DEVICE, MAKE SURE THE CARTRIDGE |
| Source | openFDA MAUDE (device adverse events) |
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