FDA Adverse Event
Injury
Summary report: N
MST8 FINAL ASSY JRZ
MDR report key: 1021961
·
Received March 10, 2008
Report
- Report Number
- 1527736-2008-01438
- Event Type
- Injury
- Date Received
- March 10, 2008
- Date of Event
- February 15, 2008
- Report Date
- February 15, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, INC. (CINCINNATI)
- Product Code
- KNW
- PMA / PMN Number
- K003297
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER COMPLETING THE BREAST BIOPSY AND TAKING POST MAMMOGRAM IMAGES THEY NOTICED THAT A PIECE OF THE PROBE HAD BROKEN OFF INTO THE PT'S BREAST. THEIR CASE WAS COMPLETED AND THE PT WAS SENT HOME UNDER NORMAL POST BIOPSY INSTRUCTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MST8 FINAL ASSY JRZ | KNW | ETHICON ENDO-SURGERY, INC. (CINCINNATI) | NA | E4K557 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | CONTROL MODULE| HOLSTER |