FDA Adverse Event
Malfunction
Summary report: N
MTOME ST HOLSTER/CABLES
MDR report key: 808912
·
Received January 10, 2007
Report
- Report Number
- 1527736-2007-00189
- Event Type
- Malfunction
- Date Received
- January 10, 2007
- Date of Event
- January 3, 2006
- Report Date
- January 3, 2007
- 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
- MA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER HAS REPORTED THAT THE STHC1 IS GIVING GREEN ERROR CODES. THE UNITED MEDICAL SYSTEMS ENGINEER HAS REQUESTED TO HAVE THE GREEN CABLE EVALUATED FOR DAMAGE. THE STHC1 IS USED ON A FISCHER SYSTEM. THE MKEY1 KEY PAD HAS A BROKEN FORWARD BUTTON. THE BUTTON WILL NOT ALLOW FOR THE CUTTER TO BECOME ACTIVATED. THE BREAST BIOPSY WAS COMPLETED. THERE WERE NO PT CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MTOME ST HOLSTER/CABLES | KNW | KNW | ETHICON ENDO-SURGERY, INC. (CINCINNATI) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | CONTROL MODULE |