FDA Adverse Event
Malfunction
Summary report: N
MATOME STEREOTACTIC 11 G PROBE
MDR report key: 1080497
·
Received July 24, 2008
Report
- Report Number
- 3005075853-2005-00376
- Event Type
- Malfunction
- Date Received
- July 24, 2008
- Date of Event
- June 16, 2008
- Report Date
- June 16, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- KNW
- PMA / PMN Number
- K991980
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 7/10/2008. INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE CUTTER RETURNED SMALL, CHOPPY SAMPLES, WAS TRANSITIONED FORWARD TO TAKE ANOTHER SAMPLE AND THE CUTTE JAMMED WHILE RETRACTING A SAMPLE AND A GREEN CABLE ERROR OCCURRED. THE CUTTER WAS ABLE TO BE RETRACTED AND A LARGE SAMPLE WAS REMOVED. A MARKER WAS PLACED AND THE PROBE WAS REMOVED WITHOUT ANY ISSUES. THE CASE WAS COMPLETED WITH NO ADVERSE PT CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MATOME STEREOTACTIC 11 G PROBE | NONE | KNW | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HOLSTER| CABLE |