FDA Adverse Event
Malfunction
Summary report: N
PEAK PLASMA BLADE 4.0
MDR report key: 3113490
·
Received April 22, 2013
Report
- Report Number
- 3113490
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Report Date
- April 22, 2013
- Manufacturer
- MEDTRONIC ADVANCED ENERGY, LLC
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MT, US
Narratives
Description of Event or Problem · 1
PLASMA PEAK BLADE WAS HOOKED UP IN THE USUAL MANNER, AND IT WOULD NOT OPERATE. MESSAGE NOTE ON SYSTEM "MACHINE CAN NOT DETECT PLASMA BLADE". CONNECTIONS WERE CHECKED DURING PROCEDURE AND THE SYSTEM WAS TURNED OFF THEN BACK ON AGAIN. DUE TO DELAY THE BOVIE DEVICE WAS USED IN PLACE OF THE PLASMA PEAK BLADE.AFTER THE CASE, BIOMED DEPARTMENT WAS CONTACTED TO CHECK THE SYSTEM. A NEW DEVICE (PLASMA PEAK BLADE) WAS USED TO CHECK THE SYSTEM AND IT CONNECTED AND WORKED FINE. THE SECOND DEVICE WAS OUT OF THE SAME LOT AS THE FIRST ONE THAT FAILED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PACEMAKER LEAD REVISION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 172508 | PEAK PLASMA BLADE 4.0 | ELECTROSURGICAL, CUTTING, COAGULATION | GEI | MEDTRONIC ADVANCED ENERGY, LLC | * | 58215 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |