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 |