FDA Adverse Event
Malfunction
Summary report: N
MATOME STEREOTACTIC 11 G PROBE
MDR report key: 1190963
·
Received October 9, 2008
Report
- Report Number
- 1527736-2008-03554
- Event Type
- Malfunction
- Date Received
- October 9, 2008
- Date of Event
- May 20, 2008
- Report Date
- May 20, 2008
- Manufacturer
- ETHICON ENDO SURGERY, INC. (CINCINNATI)
- Product Code
- KNW
- PMA / PMN Number
- K991980
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
D4; H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A BREAST BIOPSY, THE DEVICE DID NOT VACCUUM UP THE TISSUE COMPLETELY. THE DEVICE WAS NOT CLOGGED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MATOME STEREOTACTIC 11 G PROBE | NONE | KNW | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | E4KG83 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CONTROL MODULE| HOLSTER |