FDA Adverse Event
Malfunction
Summary report: N
MICRO DRILL
MDR report key: 2241616
·
Received September 2, 2011
Report
- Report Number
- 1811755-2011-03268
- Event Type
- Malfunction
- Date Received
- September 2, 2011
- Date of Event
- August 11, 2011
- Report Date
- August 11, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
VISUAL INSPECTION REVEALED CORRODED SOCKETS. CORRODED SOCKETS CAN RESULT IN INTERMITTENT CONNECTION BETWEEN THE CONSOLE AND THE HANDPIECE, AS WELL AS HIGHER IMPEDANCE AT GROUND SOCKETS.
Description of Event or Problem · 1
THE MICRO DRILL WAS SENT FOR SERVICE AND IT RAN ON ITS OWN WITHOUT ACTIVATION DURING PERFORMANCE TESTING. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO DRILL | ERL | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |