VASCULAR PROBE
Received Jul 25, 2006 · Event occurred Jun 16, 2006
Report 2183620-2006-00015 · MDR key 745675
Device
Generic name
Vessel Dilator
Manufacturer
Synovis Surgical InnovationsModel number
745105Catalog number
NA
Lot number
5714359-244554
Product problems
- Break
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE VASCULAR PROBE WAS RETURNED TO SYNOVIS SURGICAL INNOVATIONS FOR EVALUATION. THE FAILURE MODE OF THE DEVICE COULD NOT BE DUPLCATED DURING THE EVALUATION. THE DEVICE MALFUNCTION IS INCONCLUSIVE. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
PATIENT HAD A LUBAL PROCEDURE REQUIRING THE CREATION OF AN ANASTOMOSIS. THE SURGEON USED A VASCULAR PROBE TO PROVIDE STRUCTURE TO THE ANASTOMOSIS. AFTER CREATION OF THE ANASTOMOSIS, THE PROBE WAS REMOVED AND BROKE INTO 4 PIECES WHEN COMING THROUGH THE END OF THE TUBE. NO PATIENT HARM.