MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-03 for EXTENDEVAC * manufactured by Deroyal Industries.
[614713]
Esu was being used by surgeon and she was not able to turn it off and had to unplug the unit and use another device. There was no patient injury nor delay in surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 856625 |
| MDR Report Key | 856625 |
| Date Received | 2007-05-03 |
| Date of Report | 2007-05-03 |
| Date of Event | 2007-04-24 |
| Report Date | 2007-05-03 |
| Date Reported to FDA | 2007-05-03 |
| Date Added to Maude | 2007-05-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXTENDEVAC |
| Generic Name | ESU, SMOKE EVACUATION SUCTION |
| Product Code | FCZ |
| Date Received | 2007-05-03 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 11714033 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 841179 |
| Manufacturer | DEROYAL INDUSTRIES |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-03 |