FDA Adverse Event
Malfunction
Summary report: N
MST8 FINAL ASSY JRZ
MDR report key: 1272090
·
Received December 29, 2008
Report
- Report Number
- 1527736-2008-03170
- Event Type
- Malfunction
- Date Received
- December 29, 2008
- Date of Event
- May 1, 2008
- Report Date
- May 6, 2008
- Manufacturer
- ETHICON ENDO SURGERY, INC. (CINCINNATI)
- Product Code
- KNW
- PMA / PMN Number
- K003297
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 5/20/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A BREAST BIOPSY, THE FIRST PROBE WOULDN'T RETURN ANY SAMPLES. A SECOND PROBE WAS TRIED AND THE CASE WAS ABLE TO BE CONTINUED. THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MST8 FINAL ASSY JRZ | NONE | KNW | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CONTROL MODULE| HOLSTER |