FDA Adverse Event
Malfunction
Summary report: N
CORE SUMEX DRILL
MDR report key: 2943713
·
Received February 5, 2013
Report
- Report Number
- 0001811755-2013-00180
- Event Type
- Malfunction
- Date Received
- February 5, 2013
- Date of Event
- January 10, 2013
- Report Date
- January 10, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INTERNAL COMPONENTS WERE EVALUATED WHICH REVEALED THE PRESENCE OF CORROSION INTERNALLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING TESTING CONDUCTED BY THE REPAIR TECHNICIAN AT THE MANUFACTURER, THE DEVICE DISPLAYED A BIAS CURRENT ERROR WHEN CONNECTED TO THE CONSOLE, SIGNALING A CONDITION OCCURRED FROM WHICH THE DEVICE HAD THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 48255 | CORE SUMEX DRILL | DRILL, SURGICAL, ENT | ERL | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |