S-CATH M ESOPHAGEAL TEMPERATURE PROBE

Additional Manufacturer Narrative

NO TESTING COULD BE PERFORMED AS THE COMPLAINT SAMPLE HAD BEEN DISCARDED BY THE HOSPITAL. NO ALLEGED DEFECT WITH PROBE OR INSTRUCTIONS. EVENT LIKELY OCCURRED DUE TO USER PLACING PROBE DESPITE RESISTANCE BEING FELT DURING DEVICE INTRODUCTION. INSTEAD, THE USER SHOULD HAVE DETERMINED THE CAUSE OF THE RESISTANCE AND PROCEEDED ONLY AS APPROPRIATE. EXCESSIVE FORCE SHOULD NOT BE USED TO ADVANCE PROBE. TEAR IN ESOPHAGUS DUE TO DIFFICULT PLACEMENT AND FORCE USED. IT IS NOT KNOWN WHY USER HAD TROUBLE WITH INITIAL PLACEMENT OF PROBE.

Description of Event or Problem

ANESTHETIST EXPERIENCED RESISTANCE WHEN INSERTING PROBE INTO PATIENT'S OESOPHAGUS AND HAD TROUBLE WITH INITIAL PLACEMENT OF PROBE. THE ANESTHETIST RE-TRIED TO INSERT THE PROBE INTO THE PATIENT AND WAS ABLE TO PLACE THE PROBE FULLY INTO THE OESOPHAGUS. THE ABLATION PROCEDURE WAS COMPLETED SUCCESSFULLY. IN RECOVERY BAY, THE PATIENT WAS SAID TO BE COUGHING UP BLOOD AND A SCOPE WAS REQUIRED TO INVESTIGATE - AND A TEAR IN THE OESOPHAGUS HAD BEEN IDENTIFIED AND REPAIRED. THE PATIENT WAS DISCHARGED AT A LATER DATE.