MalfunctionDZH
REPAIR TPS OSC SAW
Received Sep 22, 2009 · Event occurred Aug 24, 2009
Report 1811755-2009-00554 · MDR key 1505237
Device
Generic name
Surgical Instrument Motors And Accessories/attac
Manufacturer
Stryker Instruments KalamazooCatalog number
5100031000R
Product problems
- Fluid/Blood Leak
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT BEFORE A SURGICAL PROCEDURE, A BLACK FLUID CAME OUT OF THE DEVICE. THERE WAS NO REPORTED PT OR USER INJURY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE THAT WAS ON HAND.
Additional Manufacturer Narrative
THE DEVICE HAS BEEN RECEIVED AT THE MANUFACTURER, AND A QUALITY EVALUATION WILL BE CONDUCTED. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.