MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-08 for NOVASURE * manufactured by Hologic.
[2390170]
The device was set up and ready to go (company representative was present). Dr proceeded to use the device by testing it, but it never passed the cavity assessment test. She removed the device from the patient and inserted to test again. Still it didn't pass. At this point, it was noted that there wasn't any air/co2 passing thru the filtered chamber. Md (with company rep) concluded that it was the disposable novasure device that may be the problem. We opened up another disposable device and that worked fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2461124 |
| MDR Report Key | 2461124 |
| Date Received | 2012-02-08 |
| Date of Report | 2012-02-08 |
| Date of Event | 2012-01-27 |
| Report Date | 2012-02-08 |
| Date Reported to FDA | 2012-02-08 |
| Date Added to Maude | 2012-02-17 |
| 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 | NOVASURE |
| Generic Name | ENDOMETRIAL ABLATION DISPOSABLE DEVICE |
| Product Code | MKN |
| Date Received | 2012-02-08 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 11F27RA |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-08 |