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 2019-04-19 for AFFIRM BREAST BIOPSY GUIDANCE SYSTEM STLC-00004 manufactured by Hologic, Inc.
[145541696]
It was initially reported that "needle arm needs adjustment, not sitting properly. " additional information obtained on (b)(6) 2019 noted that when the biopsy was completed the patient was released from the compression and it was noted that the needle had penetrated the breast and impacted the detector cover. The patient had not felt anything during the biopsy and no medical intervention was needed. A field engineer was dispatched to the site and determined that the bcm and bgm board needed to be replaced. Once this was completed the system was working as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220984-2019-00039 |
| MDR Report Key | 8532548 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-04-19 |
| Date of Report | 2019-04-02 |
| Date of Event | 2019-04-02 |
| Date Mfgr Received | 2019-04-02 |
| Device Manufacturer Date | 2016-03-01 |
| Date Added to Maude | 2019-04-19 |
| 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 | 2019-04-19 |
| Model Number | STLC-00004 |
| Catalog Number | STLC-00004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-04-19 |