FDA Adverse Event
Malfunction
Summary report: N
MICRODEBRIDER 1898200T IGS M4
MDR report key: 2963198
·
Received February 15, 2013
Report
- Report Number
- 1045254-2013-00115
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Date of Event
- January 28, 2013
- Report Date
- January 29, 2013
- Manufacturer
- MEDTRONIC XOMED, INC.
- Product Code
- ERL
- PMA / PMN Number
- K041413
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CORRECT MANUFACTURING DATE 02/2008.
Additional Manufacturer Narrative · 1
THE UNIT WAS NOT WORKING WHEN RECEIVED. WE COULD NOT DUPLICATE CUSTOMER'S COMPLAINT CONCERNING THE UNIT OVERHEATING. THE MOTOR/CABLE, SUBASSEMBLY, HOUSING BEARINGS AND OTHER PARTS NEEDED TO BE REPLACED DUE TO CORROSION.
Additional Manufacturer Narrative · 1
THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED HANDLE IS GETTING VERY HOT AND STOPPED WORKING DURING THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 68826 | MICRODEBRIDER 1898200T IGS M4 | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE | ERL | MEDTRONIC XOMED, INC. | 1898200T | 54527900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |