FDA Adverse Event
Malfunction
Summary report: N
STEREOGUIDE BIOPSY SYSTEM
MDR report key: 263286
·
Received February 14, 2000
Report
- Report Number
- 1220984-2000-00001
- Event Type
- Malfunction
- Date Received
- February 14, 2000
- Date of Event
- December 27, 1999
- Report Date
- February 14, 2000
- Manufacturer
- TREX MEDICAL SYSTEMS CORP
- Product Code
- HAW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE THE C-ARM MOVED DOWN WHILE THE PT WAS UNDER COMPRESSION WITH THE NEEDLE IN THE BREAST. THE PT REQUIRED 8 SUTURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEREOGUIDE BIOPSY SYSTEM | RADIOLOGIC | HAW | TREX MEDICAL SYSTEMS CORP | STG | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |