N/A
Received Nov 4, 2010 · Event occurred Sep 24, 2010
Report 2090040-2010-00014 · MDR key 1891211
Product problems
- Decrease in Suction
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A CORONARY BYPASS PROCEDURE THE VACUUM STABILIZER'S SUCTION STOPPED WORKING. ANOTHER DEVICE WAS RETRIEVED TO COMPLETE THE PROCEDURE AND NO PATIENT INJURY WAS REPORTED.
Additional Manufacturer Narrative
THE COMPLAINT DEVICE WAS EVALUATED AND IT WAS FOUND THAT DRIED ADHESIVE WAS BLOCKING THE MAJORITY OF THE TUBING CONNECTION HOLE CONTRIBUTING TO THE INSUFFICIENT SUCTION. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED DEVICE INDICATED THAT THE STABILIZER PASSED ALL APPLICABLE TESTS AND INSPECTIONS PRIOR TO RELEASE. ASCENT HAS PROCEDURES IN PLACE TO PREVENT THE ADHESIVE FROM BLOCKING THE CONNECTION. THESE PROCEDURES ARE BEING REVIEWED TO ACCESS SUITABILITY. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.