ECHELON FLEX Adverse Event — Malfunction (MDR 10004909)
ECHELON FLEX Adverse Event — Malfunction (MDR 10004909) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ECHELON FLEX; Generic name: STAPLE, IMPLANTABLE; Manufacturer: ETHICON ENDO-SURGERY, INC.
| Device | ECHELON FLEX |
|---|---|
| Generic name | STAPLE, IMPLANTABLE |
| Manufacturer | ETHICON ENDO-SURGERY, INC |
| Report number | 10004909 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Narrative | FIRST TWO STAPLE LOADS WOULD NOT ENGAGE ON STAPLER. THE THIRD LOAD ENGAGED BUT WOULDN'T FIRE. THE FOURTH LOAD FIRED BUT NEEDED MANUAL OVERRIDE TO OPEN JAWS. A NEW STAPLER HAD TO BE OPENED TO COMPLETE THE PROCEDURE. FAILED STAPLER HAD PATIENT CONTACT BUT NO PATIENT HARM. PRODUCT IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER. |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →