FDA Adverse Event
Malfunction
Summary report: N
PLASMABLADE TISSUE DISSECTION DEVICE
MDR report key: 2483234
·
Received February 20, 2012
Report
- Report Number
- 3007069406-2012-00067
- Event Type
- Malfunction
- Date Received
- February 20, 2012
- Date of Event
- October 10, 2011
- Report Date
- October 10, 2011
- Manufacturer
- PEAK SURGICAL, INC.
- Product Code
- GEI
- PMA / PMN Number
- K073057
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DURING THE CASE, A PEAK'S REPRESENTATIVE NOTICED THAT THE FOOT SWITCH/PEDAL REMAINED ENGAGED. THE COAG SETTING WAS CHANGED ON THE GENERATOR, WHICH DISENGAGED THE FOOTSWITCH. NO PT IMPACT REPORTED. GENERATOR ASSOCIATED WITH THE FOOTSWITCH WAS EVALUATED BY THE MANUFACTURER (SINCE THE FOOTSWITCH CANNOT OPERATE WITHOUT THE GENERATOR) AND NO ERRORS OR FAULTS WERE EXHIBITED DURING EVALUATION.
Description of Event or Problem · 1
DURING A CASE THE WIRELESS FOOT PEDAL REMAINED ACTIVE WHEN THE PEDAL WAS RELEASED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLASMABLADE TISSUE DISSECTION DEVICE | GEI | PEAK SURGICAL, INC. | WIRELESS FOOTSWITCH | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NOT AVAILABLE |