FDA Adverse Event
Malfunction
Summary report: N
11G BLADED MAMMOTOME ST PROBE
MDR report key: 681232
·
Received February 27, 2006
Report
- Report Number
- 1527736-2006-00825
- Event Type
- Malfunction
- Date Received
- February 27, 2006
- Report Date
- February 2, 2006
- Manufacturer
- ETHICON ENDO SURGERY, INC.
- Product Code
- KNW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. 510(K)# IS K991980.
Description of Event or Problem · 1
PLASTIC SHAVINGS ALONG WITH THE SPECIMENT WERE IN THE COLLECTION CHAMBER. THE DOCTOR WAS ABLE TO FINISH THE BREAST BIOPSY WITHOUT CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 11G BLADED MAMMOTOME ST PROBE | MAMMOTOME PROBES | KNW | ETHICON ENDO SURGERY, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |