FDA Adverse Event
Malfunction
Summary report: N
INTEGRATED POWER CONSOLE (IPC)
MDR report key: 2190475
·
Received July 29, 2011
Report
- Report Number
- 2190475
- Event Type
- Malfunction
- Date Received
- July 29, 2011
- Date of Event
- November 23, 2010
- Report Date
- July 20, 2011
- Manufacturer
- MEDTRONIC POWERED SURGICAL SOLUTIONS
- Product Code
- HBE
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PHYSICIAN WAS PERFORMING A C6-TF (TRANSVERSE FORAMEN) LAMINECTOMY FOR AN EPIDURAL MASS. DURING THE PROCESS OF USING THE HIGH SPEED MIDAS REX DRILL, THE DRILL BECAME VERY HOT. AN ABNORMAL SMELL WAS DETECTED OUT OF THE DRILL AS WELL. UPON TOUCHING THE DRILL, A HIGH DEGREE OF TEMPERATURE WAS DETECTED. THE DRILL WAS, THEREFORE, DROPPED OFF THE FIELD ONTO THE SIDE WHERE A BURN WAS VISIBLE ON THE DRAPE AWAY FROM THE PATIENT. THE DOCTOR'S HAND RECEIVED A BURN FROM THE HANDPIECE. NO HARM TO PATIENT. PROCEDURE COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTEGRATED POWER CONSOLE (IPC) | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | HBE | MEDTRONIC POWERED SURGICAL SOLUTIONS | * | * | |
| 2 | IPC STYLUS FOOT PEDAL | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | HBE | MEDTRONIC POWERED SURGICAL SOLUTIONS | * | * | |
| 3 | STYLUS DRILL | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | HBE | MEDTRONIC POWERED SURGICAL SOLUTIONS | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |