FDA Adverse Event
Malfunction
Summary report: N
DRILL 3334800 VISAO 80K HANDPIECE
MDR report key: 2863447
·
Received December 10, 2012
Report
- Report Number
- 1045254-2012-00704
- Event Type
- Malfunction
- Date Received
- December 10, 2012
- Report Date
- November 9, 2012
- Manufacturer
- MEDTRONIC XOMED, INC.
- Product Code
- ERL
- PMA / PMN Number
- K011321
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR SERVICE AND REPAIR. THE CUSTOMER'S COMPLAINT COULD NOT VERIFY THE LEAKING OR THE OVERHEATING OF THE DEVICE. FURTHER ANALYSIS DID IDENTIFY CORRODED NOSE BEARINGS. THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE CONFIRMED. THE UNIT RECEIVED PREVENTATIVE MAINTENANCE, WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. THE DEVICE WAS RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED TO THE MANUFACTURER'S SERVICE AND REPAIR DEPARTMENT THAT THE HANDPIECE WAS NOT RUNNING WELL AND WAS OVERHEATING WITH THE COOLING SYSTEM WORKING. THERE WAS NO REPORT OF PATIENT IMPACT OR INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DRILL 3334800 VISAO 80K HANDPIECE | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE | ERL | MEDTRONIC XOMED, INC. | 3334800 | 38901200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |