FDA Adverse Event
Malfunction
Summary report: N
MAMMOTOME CONTROL MODULES
MDR report key: 721934
·
Received June 2, 2006
Report
- Report Number
- 1527736-2006-02510
- Event Type
- Malfunction
- Date Received
- June 2, 2006
- Date of Event
- May 16, 2006
- Report Date
- May 17, 2006
- Manufacturer
- ETHICON ENDO-SURGERY, INC. (CINCINNATI)
- Product Code
- KNW
- PMA / PMN Number
- K991980
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE DC MOTOR ADAPTER WAS FOUND BROKEN ON THE BLUE CABLE SIDE OF THE CONTROL MODULE. SINCE IT WAS NEAR THE END OF THE CASE, NO PT CONSEQUENCE OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAMMOTOME CONTROL MODULES | KNW | KNW | ETHICON ENDO-SURGERY, INC. (CINCINNATI) | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |