FDA Adverse Event
Malfunction
Summary report: N
E.S. UNIT, F2-8PC UPGRADE
MDR report key: 1001286
·
Received February 15, 2008
Report
- Report Number
- 1717344-2008-00053
- Event Type
- Malfunction
- Date Received
- February 15, 2008
- Date of Event
- January 18, 2008
- Report Date
- January 20, 2008
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE OF INITIAL REPORT : 02/19/2008. THE GENERATOR WAS RETURNED TO AND TESTED BY COVIDIEN AND FOUND TO FUNCTION TO SPECIFICATION. FOLLOW-UP MEETINGS WITH HOSPITAL REPRESENTATIVES TOOK PLACE TO DISCUSS THE INCIDENT. PROBABLE CAUSE WAS BELIEVED TO BE USER ERROR WHEN AN ES PENCIL WAS LAID NEXT TO THE PATIENT'S ARM AND WAS ACTIVATED WHEN THE FOOT PEDAL WAS ACCIDENTALLY PUSHED.
Description of Event or Problem · 1
THE REPORT STATED A PATIENT HAS BEEN BURNED ON THE LEFT ARM. IT IS A BURN OF APPROXIMATELY 20MM LONG X 5MM WIDE. THE HOSPITAL DOES NOT USE COVIDIEN PENCILS, ELECTRODES OR PATIENT RETURN ELECTRODES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | E.S. UNIT, F2-8PC UPGRADE | ELECTROSURGICAL GENERATOR | GEI | COVIDIEN LP (VALLEYLAB) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |