RUSCH MALLONEY FR28F
Received Jan 5, 2011 · Event occurred Jan 4, 2011
Report MW5018908 · MDR key 1957358
Device
Product problems
- Fluid/Blood Leak
- Material Perforation
Patient
64 YR
- Chemical Exposure
Narrative
Description of Event or Problem
PT SCHEDULED FOR LAPAROSCOPIC ROUX-EN-Y PROCEDURE. DIFFICULT PLACEMENT OF NG TUBE REQUIRING PLACEMENT OF BOUGIE DILATOR TO ASSIST IN NG INSERTION WHICH WAS FINAL PHASE OF OPERATIVE PROCEDURE TO ASSURE NO EVIDENCE OF LEAK. BOUGIE WAS A RUSCH HURST STYLE MANUFACTURED PRIOR TO 2003. BOUGIE WAS MODIFIED TO ASSIST IN THE INSERTION OF THE NASOGASTRIC TUBE. A SUTURE WAS PLACED THROUGH ONE END OF THE DILATOR WITH A TAIL OF SUTURE MATERIAL ATTACHED. IT WAS DISCOVERED THAT THE SUTURE HAD APPARENTLY PUNCTURED THE INNER LUMEN OF THE DILATOR, ALLOWING MERCURY TO ESCAPE OUTSIDE OF THE DILATOR. FREQUENCY: 10 MINUTES X1. ROUTE: NASAL. DATES OF USE: 10 MINUTES. DIAGNOSIS OR REASON FOR USE: ASSIST IN PLACEMENT OF NASOGASTRIC TUBE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.