MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-22 for WET-FIELD HEMOSTATIC ERASER * 221265 manufactured by Medtronic Ophthalmics.
[1892863]
Physician noticed that the bipolar probe was not coagulating blood vessels and then the handpiece heated up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2036937 |
| MDR Report Key | 2036937 |
| Date Received | 2011-03-22 |
| Date of Report | 2011-03-22 |
| Date of Event | 2011-01-13 |
| Report Date | 2011-03-22 |
| Date Reported to FDA | 2011-03-22 |
| Date Added to Maude | 2011-04-01 |
| 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 | WET-FIELD HEMOSTATIC ERASER |
| Generic Name | BIPOLAR PROBE |
| Product Code | HQR |
| Date Received | 2011-03-22 |
| Model Number | * |
| Catalog Number | 221265 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC OPHTHALMICS |
| Manufacturer Address | 7611 NORTHLAND DRIVE MINNEAPOLIS MN 55432 US 55432 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-22 |