FDA Adverse Event
Malfunction
Summary report: N
CORE MICRO DRILL
MDR report key: 3080287
·
Received April 26, 2013
Report
- Report Number
- 0001811755-2013-00912
- Event Type
- Malfunction
- Date Received
- April 26, 2013
- Date of Event
- April 5, 2013
- Report Date
- April 8, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER DECIDED NOT TO RETURN THE DEVICE FOR REPAIR BECAUSE THE DEVICE ONLY DISPLAYS AN ERROR ON ONE CONSOLE, AND DOESN'T DISPLAY AN ERROR ON THEIR OTHER CONSOLE. CUSTOMER DECIDED NOT TO RETURN THE DEVICE FOR REPAIR.
Description of Event or Problem · 1
WHILE TESTING THE CORE MICRO DRILL WAS TESTED IT DISPLAYED A BIAS CURRENT MESSAGE WHEN CONNECTED TO THE CONSOLE, SIGNALING A CONDITION OCCURRED FROM WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES TO THE USER ALLEGED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183087 | CORE MICRO DRILL | DRILL, SURGICAL, ENT (ELECTRIC | ERL | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |