MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-02-07 for AFFIRM PRONE BIOPSY SYSTEM, 3D PBX-SYS-AFFIRM-3D manufactured by Hologic, Inc.
[178627299]
As of today the investigation is in process and a follow up will be filed as needed.
Patient Sequence No: 1, Text Type: N, H10
[178627300]
It was reported that the stage arm brake was not working. Additional information noted that due to this issue the needle moved in the patient breast. No injury reported. Additional images were required to complete the procedure resulting in additional radiation. A field engineer was dispatched to the site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220984-2020-00018 |
| MDR Report Key | 9683753 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-02-07 |
| Date of Report | 2020-01-20 |
| Date Mfgr Received | 2020-03-20 |
| Date Added to Maude | 2020-02-07 |
| 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 |
| 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 PRONE BIOPSY SYSTEM, 3D |
| Generic Name | BREAST BIOPSY SYSTEM |
| Product Code | IZH |
| Date Received | 2020-02-07 |
| Model Number | PBX-SYS-AFFIRM-3D |
| Catalog Number | PBX-SYS-AFFIRM-3D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-02-07 |