GENERAL PURPOSE PROBE

Additional Manufacturer Narrative

ROOT CAUSE: AFTER INVESTIGATION, IT WAS DETERMINED THE REPORTED ISSUE WAS DUE TO USE ERROR. THE PRODUCT IS INTENDED TO BE USED IN THE ESOPHAGUS OR RECTUM. ADDITIONALLY, THERE IS A WARNING IN THE INSTRUCTIONS FOR USE PACKAGED WITH THE PRODUCT THAT "TRACHEAL OR BRONCHIAL INSERTION OF THE PROBE MAY CAUSE AIRWAY OBSTRUCTION AND MAY BE FATAL IF UNCORRECTED." CORRECTIVE ACTION: A CORRECTIVE ACTION HAS NOT BEEN TAKEN DUE TO THE ROOT CAUSE DETERMINATION. A MEDWATCH REPORT WAS RECEIVED INDICATING A GENERAL PURPOSE PROBE (PART 81-020409) WAS FOUND IN THE RIGHT MAINSTEM BRONCHUS DURING A TRANSESOPHAGEAL TEMPERATURE MONITORING. THE DEFECTIVE DEVICE WAS NOT RETURNED FOR EVALUATION. THE REPORTED LOT NUMBER IS NOT RECOGNIZED BY DEROYAL; THEREFORE, NO WORK ORDER REVIEW COULD BE PERFORMED. PRODUCT IN PROCESS WAS NOT INSPECTED. NONE OF THE POTENTIAL DEFECTS THAT MAY APPEAR DURING THE REGULAR MANUFACTURING PROCESS ARE RELATED TO THE REPORTED ISSUE. THE DEVICE IS INTENDED TO BE USED IN THE ESOPHAGUS OR RECTUM. THIS IS IDENTIFIED IN THE INSTRUCTIONS FOR USE, WHICH ARE PACKAGED WITH THE PRODUCT. ADDITIONALLY, THE INSTRUCTIONS FOR USE ALSO CONTAIN THE FOLLOWING WARNING, " TRACHEAL OR BRONCHIAL INSERTION OF THE PROBE MAY CAUSE AIRWAY OBSTRUCTION AND MAY BE FATAL IF UNCORRECTED." IN THE PAST TWO YEARS, DEROYAL HAS RECEIVED TWO INTERNAL COMPLAINTS FOR THE REPORTED PART NUMBER. HOWEVER, NEITHER OF THESE COMPLAINTS WAS RELATED TO THE REPORTED ISSUE. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW OR CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

Description of Event or Problem

A TEMPERATURE PROBE WAS FOUND IN THE RIGHT MAINSTEM BRONCHUS DURING TRANSESOPHAGEAL TEMPERATURE MONITORING.