FDA Adverse Event
Malfunction
Summary report: N
ATEC BIOPSY SYSTEM
MDR report key: 1502233
·
Received September 14, 2009
Report
- Report Number
- 3003862400-2009-00004
- Event Type
- Malfunction
- Date Received
- September 14, 2009
- Date of Event
- November 18, 2008
- Report Date
- September 11, 2009
- Manufacturer
- HOLOGIC, INC.
- Product Code
- KNW
- PMA / PMN Number
- K042290
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PROBLEM DESCRIPTION: DR. (B)(6) REPORTED TO HOLOGIC THAT ONE ATEC 1209-20 TOOK SIX NORMAL PASSES OF TISSUE SAMPLES THEN A "BURST OF AIR" AND THE DEVICE GOT STUCK AND STOPPED WORKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATEC BIOPSY SYSTEM | VACUUM ASSISTED BREAST BIOPSY | KNW | HOLOGIC, INC. | ATEC 1209-20 | 809091 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |