FDA Adverse Event
Malfunction
Summary report: N
FINESSE ULTRA BIOPSY PROBE
MDR report key: 2113408
·
Received May 23, 2011
Report
- Report Number
- 2020394-2011-00112
- Event Type
- Malfunction
- Date Received
- May 23, 2011
- Report Date
- April 20, 2011
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- KNW
- PMA / PMN Number
- K093068
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE LOT NUMBER IS UNKNOWN. THE DEVICE HAS NOT BEEN RETURNED, AS IT WAS DISCARDED BY THE USER FACILITY. THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION OF THIS EVENT IS UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A BREAST BIOPSY, THE QUALITY OF THE SAMPLES RECEIVED WERE NOT SATISFACTORY AS THEY APPEARED TO BE "CRUSHED". ALLEGEDLY, AS A RESULT, THE PATHOLOGIST INCORRECTLY DIAGNOSED THE STAGE OF THE CANCER. AT THIS TIME, NO ADDITIONAL INFORMATION IS KNOWN REGARDING THE PATIENT STATUS OR THE TYPE OF TREATMENT GIVEN FOR THE CANCER. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINESSE ULTRA BIOPSY PROBE | KNW | BARD PERIPHERAL VASCULAR, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |