RELOADS FOR LINEAR CUTTERS Adverse Event — Malfunction (MDR 3005075853-2020-02355)
RELOADS FOR LINEAR CUTTERS Adverse Event — Malfunction (MDR 3005075853-2020-02355) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: RELOADS FOR LINEAR CUTTERS; Generic name: STAPLE, IMPLANTABLE; Manufacturer: ETHICON ENDO-SURGERY, LLC..
| Device | RELOADS FOR LINEAR CUTTERS |
|---|---|
| Generic name | STAPLE, IMPLANTABLE |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Report number | 3005075853-2020-02355 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | (B)(4). BATCH # UNK. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION RECEIVED: DID THE DEVICE DELIVER STAPLES? YES. IF YES, WERE THE STAPLES FORMED CORRECTLY? THE STAPLE LINE DID NOT FORM CORRECTLY, LEAVING SOME STAPLES OPEN. IF SO, WAS THE STAPLE LINE COMPLETE? YES. DID THE DEVICE CUT? YES. IF YES, |
| Source | openFDA MAUDE (device adverse events) |
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