MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-12-11 for BIOPSYS C1530 * manufactured by Biopsys Medical, Inc..
[117852]
End of marker stylette noted to be broken after removal of the stylette during removal of core tissue samples during a stereotactic breast biopsy. Pt was radiographed digitally with stereotactic equipment. No clip or broken plastic tip was noted in breast. Mfr notified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1015221 |
| MDR Report Key | 201805 |
| Date Received | 1998-12-11 |
| Date of Report | 1998-12-09 |
| Date of Event | 1998-12-02 |
| Date Added to Maude | 1998-12-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOPSYS |
| Generic Name | MAMMOTOME NEEDLE/MICRO MARKER CLIP |
| Product Code | MJG |
| Date Received | 1998-12-11 |
| Model Number | C1530 |
| Catalog Number | * |
| Lot Number | N6049 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 196014 |
| Manufacturer | BIOPSYS MEDICAL, INC. |
| Manufacturer Address | 3 MORGAN IRVINE CA 92718 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-12-11 |