EHD STERNUM SAW
Received Nov 13, 2009 · Event occurred Oct 14, 2009
Report 1811755-2009-00770 · MDR key 1542787
Device
Generic name
Surgical Instrument Motors And Accessories/attachment
Manufacturer
Stryker Instruments KalamazooCatalog number
0296097000
Product problems
- Fluid/Blood Leak
Patient
UNK
- Chemical Exposure
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING AN AORTIC VALVE REPLACEMENT, OIL LEAKED FROM THE TOP OF THE HANDPIECE INTO THE CHEST CAVITY. THE SITE WAS IMMEDIATELY IRRIGATED. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED REGARDING THE STATUS OF THE PATIENT, DESPITE NUMEROUS ATTEMPTS.
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. ACCORDING TO THE INFORMATION RECEIVED FROM THE RISK MANAGEMENT DEPARTMENT AT THE ACCOUNT, THE HANDPIECE WILL NOT BE RETURNED UNTIL AN INTERNAL INVESTIGATION IS COMPLETE. IF THE DEVICE IS RETURNED TO THE MANUFACTURER, A FOLLOW UP REPORT WILL BE FILED.