POWERED PLUS STANDARD 45 Adverse Event — Malfunction (MDR 3005075853-2020-02359)
POWERED PLUS STANDARD 45 Adverse Event — Malfunction (MDR 3005075853-2020-02359) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: POWERED PLUS STANDARD 45; Generic name: STAPLE, IMPLANTABLE; Manufacturer: ETHICON ENDO-SURGERY, LLC..
| Device | POWERED PLUS STANDARD 45 |
|---|---|
| Generic name | STAPLE, IMPLANTABLE |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Report number | 3005075853-2020-02359 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | USER FACILITY |
| Narrative | (B)(4). BATCH #UNK. (B)(4). AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS EVALUATION COULD NOT BE PER |
| Source | openFDA MAUDE (device adverse events) |
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