FDA Adverse Event
Malfunction
Summary report: N
MAMMOTOME EX
MDR report key: 726016
·
Received June 7, 2006
Report
- Report Number
- 1527736-2006-02602
- Event Type
- Malfunction
- Date Received
- June 7, 2006
- Date of Event
- May 12, 2006
- Report Date
- May 12, 2006
- Manufacturer
- ETHICON ENDO SURGERY, INC.(CINCINNATI)
- Product Code
- KNW
- PMA / PMN Number
- k033700
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.(510(K)#K033700)
Description of Event or Problem · 1
IT WAS REPORTED BY THE CUSTOMER THAT WHILE SETTING UP FOR A BREAST BIOPSY, THEY HAD DIFFICULTY LOADING THE 11 G PROBE INTO THE HOLSTER. THEY CHANGED PROBES AND COMPLETED THE CASE WITH NO CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAMMOTOME EX | KNW | KNW | ETHICON ENDO SURGERY, INC.(CINCINNATI) | NA | C4DY18 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | HOLSTER| CONTROL MODULE |