FDA Adverse Event
Malfunction
Summary report: N
PULSAR GENERATOR
MDR report key: 2821269
·
Received October 25, 2012
Report
- Report Number
- 3007069406-2012-00224
- Event Type
- Malfunction
- Date Received
- October 25, 2012
- Date of Event
- July 25, 2012
- Report Date
- August 10, 2012
- Manufacturer
- MEDTRONIC ADVANCED ENERGY LLC
- Product Code
- GEI
- PMA / PMN Number
- K082786
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MANUFACTURER FOR THE TIME PERIOD 08/15/2010 THROUGH 08/15/2012. RETURN OF THE DEVICE WAS INDICATED, HOWEVER AS OF 10/22/2012, THE DEVICE HAS NOT BEEN RETURNED. REVIEW OF THE LOT HISTORY RECORD REVEALED NO ANOMALIES. END OF REPORT.
Description of Event or Problem · 1
IT WAS REPORTED DURING SURGERY, THE UNIT SPONTANEOUSLY DISPLAYED AN ERROR CODE E2 (CUT OR COAG FOOT PEDAL MAY BE STUCK IN THE ON POSITION). THERE WERE NO PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSAR GENERATOR | GEI | MEDTRONIC ADVANCED ENERGY LLC | PULSAR I | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | PLASMABLADE| FOOT PEDAL: (B)(4) |