FDA Adverse Event
Malfunction
Summary report: N
MAMMOTOME CONTROL MODULES
MDR report key: 726409
·
Received June 13, 2006
Report
- Report Number
- 1527736-2006-02689
- Event Type
- Malfunction
- Date Received
- June 13, 2006
- Date of Event
- May 11, 2006
- Report Date
- May 11, 2006
- Manufacturer
- ETHICON ENDO SURGERY, INC.(CINCINNATI)
- Product Code
- KNW
- PMA / PMN Number
- k99190
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
H3. EVALUATION: BASED UPON THE INQUIRY INFO RECEIVED VISUAL AND FUNCTUINAL EXAMINATION: THE UNIT WAS FOUND TO REQUIRE THE INTERFACE BOARD AND BLACK CABLE REPLACED. THE DEVICE WAS FUNCTIONALLY TESTED, MET ALL PRODUCT REQUIREMENTS AND RETURNED TO THE CUSTOMER. 510(K) NUMBER IS K99190.
Description of Event or Problem · 1
THE CUSTOMER HAS REQUESTED TO HAVE CERTIFICATION ON THE MOMMOTOME SCM12 CONTROL MODULE. NO PT CONSEQUENCES REPORTED.
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 | 1.PROBE, 2.HOLSTER. |