MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-05-10 for AFFIRM BREAST BIOPSY GUIDANCE SYSTEM STLC-00004 manufactured by Hologic, Inc.
[145268095]
It was reported that a superficial lesion was targeted and when the needle fired, it struck the detector. The biopsy was successfully completed and no additional intervention was required. A field engineer was dispatched to the site and it was determined that after a software upgrade the needle parameters were not enabled. The technologist selected an eviva 9g x13cm petite thinking it was the same as eviga 9gx13cm standard 20mm, which was not availabe/visible because it was not yet enabled. The correct needle type was enabled in the application. Once this was completed the system was working as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220984-2019-00050 |
| MDR Report Key | 8601140 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-10 |
| Date of Report | 2019-04-26 |
| Date of Event | 2019-04-26 |
| Date Mfgr Received | 2019-04-26 |
| Device Manufacturer Date | 2015-09-01 |
| Date Added to Maude | 2019-05-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KRISTIN FORNIERI |
| Manufacturer Street | 36 & 37 APPLE RIDGE ROAD |
| Manufacturer City | DANBURY CT 06810 |
| Manufacturer Country | US |
| Manufacturer Postal | 06810 |
| Manufacturer Phone | 2037318491 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AFFIRM BREAST BIOPSY GUIDANCE SYSTEM |
| Generic Name | BIOPSY GUIDANCE SYSTEM |
| Product Code | IZH |
| Date Received | 2019-05-10 |
| Model Number | STLC-00004 |
| Catalog Number | STLC-00004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 36 & 37 APPLE RIDGE ROAD DANBURY CT 06810 US 06810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-10 |