FDA Adverse Event
Malfunction
Summary report: N
MST8 FINAL ASSY JRZ
MDR report key: 1512863
·
Received October 21, 2009
Report
- Report Number
- 3005075853-2009-06360
- Event Type
- Malfunction
- Date Received
- October 21, 2009
- Date of Event
- September 24, 2009
- Report Date
- September 28, 2009
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- KNW
- PMA / PMN Number
- K003297
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4). (B) (4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A STEREOTACTIC BREAST BIOPSY PROCEDURE, THE DEVICE WAS UNABLE TO GET CORE SAMPLES. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MST8 FINAL ASSY JRZ | PROBE | KNW | ETHICON ENDO-SURGERY, LLC. | UNK | F4P65K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |