MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-17 for EVIVA * EVIVA 0913-20 manufactured by Hologic, Inc..
[5033076]
During pre-check on the biopsy probe, it failed to fire again after first check. Button use to set probe to pre-fire again failed after first check. All this was found prior to use on the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4260928 |
| MDR Report Key | 4260928 |
| Date Received | 2014-11-17 |
| Date of Report | 2014-11-17 |
| Date of Event | 2014-11-12 |
| Report Date | 2014-11-17 |
| Date Reported to FDA | 2014-11-17 |
| Date Reported to Mfgr | 2014-11-19 |
| Date Added to Maude | 2014-11-19 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | EVIVA |
| Generic Name | BIOPSY PUNCH |
| Product Code | FCI |
| Date Received | 2014-11-17 |
| Model Number | * |
| Catalog Number | EVIVA 0913-20 |
| Lot Number | 14G04RB |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 250 CAMPUS DRIVE MALBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-17 |