FDA Adverse Event
Summary report: N
CORE SUMEX
MDR report key: 3181502
·
Received June 11, 2013
Report
- Report Number
- 3181502
- Date Received
- June 11, 2013
- Date of Event
- May 28, 2013
- Report Date
- June 11, 2013
- Manufacturer
- STRYKER INSTRUMENTS
- Product Code
- HBE
- Report Source
- User Facility report
- Reporter Location
- MA, US
Narratives
Description of Event or Problem · 1
THE HAND HELD DRILL OVERHEATED AND BURNED THROUGH TWO SETS OF GLOVES THAT THE SURGEON WAS WEARING. THIS RESULTED IN HIS THUMB BEING SLIGHTLY BURNED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?THE SURGEON'S WERE PERFORMING A RIGHT CRANIOTOMY FOR TUMOR.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 263816 | CORE SUMEX | DRILL | HBE | STRYKER INSTRUMENTS | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | (REF #5400-71-59) WAS ON THE DRILL AT THE TIME OF| D-59 TAPERED ROUTER 1.7MMX 25.0 MM| INSTRUMENT DRIVER WAS SET AT 75,000 RPM AND THE| CORE POWER INSTRUMENT DRIVER (#1103206). THE| YES, THE DRILL WAS BEING POWERED BY THE STRYKER| NO OTHER THERAPIES |